JP6835797B2 - Pressure regulation system, pressure regulation syringe assembly, and method of transferring liquid - Google Patents

Description

The present application is a US patent provisional application No. 61 / 856,593 entitled "PRESSURE-REGULATING FLUID TRANSFER SYSTEMS AND METHODS" filed on July 19, 2013, and Claims the interests of US Patent Application No. 61 / 936,785, entitled "PRESSURE-REGULATING FLUID TRANSFER SYSTEMS AND METHODS", filed February 6, 2014. The entire provisional application is incorporated herein by reference and is incorporated herein by reference.

One embodiment disclosed herein is a pressure regulation system and its components linked to a drug container (eg, a vial and / or bag), as well as holding and / or pressure regulation of vapors within the drug container. Regarding how to assist. Some embodiments relate to pressure regulating syringe assemblies.

Drugs and other medical fluids are generally stored in vials or other containers.

In some examples, drugs or fluids stored in vials or other containers have therapeutic effects when injected into the bloodstream of a patient, but are inhaled by a non-patient, such as a healthcare provider. Or if you touch the bare skin, it is harmful. Certain known systems for withdrawing potentially harmful drugs from vials have various drawbacks. Therefore, it is necessary to store and / or control the drug so that it can be properly administered to patients without accidental administration to non-patients.

In some embodiments, the syringe assembly may include a housing and a plunger slidably coupled to the housing. The housing may have a distal portion and a proximal portion. The plunger may have a distal plunger seal, a proximal plunger seal, and an internal channel, the proximal plunger seal sliding distally within the internal channel and / or proximally within the internal channel. It is configured to do. The syringe assembly may include a first reservoir located within the distal portion of the plunger's internal channel and a second reservoir located within the distal portion of the housing.

In some embodiments, the syringe assembly has a third reservoir that is located within the proximal portion of the inner channel of the plunger and is separated (eg, sealed) from the first reservoir by a proximal plunger seal. Can include. Another part of the plunger or syringe may include a hole configured to fluidly connect the third reservoir to the surrounding environment outside the syringe assembly. The plunger may include a vent that is configured to equalize the pressure in the third reservoir with the ambient pressure. In some embodiments, the plunger may include a vent that is configured to adjust the pressure in the third reservoir relative to the ambient pressure. The proximal plunger seal may be configured to slide within the internal channel in response to a pressure difference between the proximal side of the proximal plunger seal and the distal side of the proximal plunger seal.

In some embodiments, the syringe assembly may include a housing having a distal portion and a proximal portion. The syringe assembly may have a plunger that is slidably connected to the housing. The plunger may have a distal plunger seal and a proximal plunger seal. The syringe assembly may include a first reservoir. In some embodiments, the syringe assembly may include a second reservoir that is located within the distal portion of the housing. The first passage may be configured to allow fluid to communicate from the first reservoir to the distal portion of the housing. The first passage may be located radially outward from the first reservoir and may be configured to be fluidly isolated from the second reservoir.

In some embodiments, the first reservoir may be located within a portion of the plunger. The plunger may have an internal channel and the proximal plunger seal may be configured to slide distally within the internal channel. In some embodiments, the first and second reservoirs are volumetrically independent. In some embodiments, the first fluid reservoir regulates the pressure of the gas in the vessel. The second fluid reservoir receives the liquid from the container and / or adds the liquid to the container. In some embodiments, the first fluid reservoir has a first maximum volume and the second fluid reservoir has a second maximum volume. The first maximum volume can be at least half the size of the second maximum volume.

In some embodiments, the second fluid reservoir is located distal relative to the first fluid reservoir and / or the first fluid reservoir is relative to the third fluid reservoir. It is located distal to. The plunger may include an internal channel. The seal can be slidably connected within the internal channel. The first fluid reservoir may be located relative to the seal and the third fluid reservoir may be located relative to the seal.

In some embodiments, the first fluid reservoir may have an outer diameter and the third fluid reservoir may have an outer diameter. The outer diameter of the first fluid reservoir can be approximately the same as the outer diameter of the third fluid reservoir. In some embodiments, the first fluid reservoir and the third fluid reservoir are approximately the same diameter. The second fluid reservoir may have an outer diameter that is greater than the outer diameter of the first fluid reservoir and greater than the outer diameter of the third fluid reservoir. In some variants, the plunger comprises a third fluid reservoir (eg, a peripheral portion), which may be fluid connected to the surrounding environment. The third fluid reservoir can be separated from the first fluid reservoir by one or more seals.

In some embodiments, the plunger comprises a barrel, which may define at least a portion of the second fluid reservoir. The plunger can be slidably coupled to the barrel and can be configured to slide within at least a portion of the barrel. The syringe assembly may include a distal end that is configured to be connected to a container. In some embodiments, the syringe assembly fluidly connects a first fluid reservoir to the distal end with a first passage configured to fluidly connect the first fluid reservoir to the distal end. Includes a second passage configured as such.

In some embodiments, the one or more seals include a rigid inner body and a compliant sealing member. The sealing member fluidly seals the inner surface of the plunger. The responsive sealing member may be placed around at least a portion of the rigid inner body. In some embodiments, the first fluid reservoir has a proximal end, which is configured to move as the seal slides within the plunger.

In some practices, the plunger includes a container that can be expanded and contracted, such as a bag, balloon, etc. The first fluid reservoir may be placed in the bag.

In some embodiments, the expansion chamber may be configured to have fluid communication with the second passage. The expansion chamber can be configured to expand from a first volume to a second volume when the syringe assembly is disconnected from a device (eg, an adapter assembly) that connects the syringe assembly to the container. The second volume can be larger than the first volume.

In some embodiments, the syringe assembly may be configured to connect with an adapter assembly that is configured to connect with the container. The syringe assembly may include a housing with a distal portion. The syringe assembly may also include a plunger having an internal channel and a distal channel. The plunger may be slidably connected to the housing. The syringe assembly may also include a first reservoir that is located within the internal channel of the plunger and is configured to contain the conditioning fluid. In some embodiments, the syringe assembly may include a second reservoir that is located within the distal portion of the housing. The distal seal of the plunger may be configured to slide within the housing to change the volume of the second reservoir. The syringe assembly may also include a proximal seal that is configured to slide within the internal channel of the plunger, thereby varying the volume of the first reservoir.

In some embodiments, when the syringe assembly is connected to the container via an adapter assembly, the first reservoir may be configured to deliver at least a portion of the conditioning fluid to the container, the second. The reservoir may be configured to receive at least a portion of the liquid from the container. In some embodiments, when the syringe assembly is connected to the container via an adapter assembly, the first reservoir may be configured to receive gas from the container and the second reservoir may receive liquid. It can be configured to deliver to a container. In some embodiments, when the syringe assembly is not connected to the adapter assembly, the first reservoir and the second reservoir are substantially and / or effectively sealed from each other and / or from the surrounding environment. It is configured to be stopped.

In some embodiments, the first reservoir may be located between the distal and proximal seals. The second reservoir can be located distal relative to the distal seal. Some systems may include a conditioning channel that is configured to communicate the conditioning fluid from the first reservoir to the vessel. In some embodiments, at least a portion of the adjustment channel may be located radially outward from the first reservoir. In some embodiments, at least a portion of the adjustment channel may be located radially outward from the second reservoir. Some systems include a drawing channel that is configured to allow liquid to communicate from the container to the second reservoir.

In some embodiments, the syringe assembly comprises a first spring and an adjustment channel seal. The first spring may be configured to apply an axial force to press the adjustment channel seal against the sealing surface, thereby sealing the adjustment channel. Some embodiments may include a conditioning channel that is configured to communicate the conditioning fluid from the first reservoir to the vessel. Some systems include a first spring and an adjustment channel seal. The first spring may be configured to apply an axial force to press the adjustment channel seal against the sealing surface, thereby sealing the adjustment channel.

Some embodiments include penetrating members. Penetration members can be placed on the adapter, which can be connected to medical containers such as syringe assemblies and vials. The penetrating member can penetrate the septum of the vial when the adapter is connected to the vial. Some embodiments of the syringe assembly and / or the adapter assembly do not include a needle.

In some embodiments, the syringe assembly may be configured to connect to the adapter assembly without requiring a particular direction of rotation relative to the adapter assembly.

In some embodiments, the pressure regulating system for the transfer of medical fluid may include an adapter assembly. The adapter assembly may be connectable with medical vials and syringe assemblies. The syringe assembly may be configured to connect (eg, permanently or detachably) with the adapter assembly.

In some embodiments, the syringe assembly comprises a housing having a distal portion and a first reservoir. The first reservoir may be located within the internal channel of the syringe assembly and may contain a certain amount of conditioning fluid, such as gas and / or liquid. The syringe assembly may include a second reservoir located within the distal portion of the housing. The syringe assembly may include a proximal seal that is configured to slide within an internal channel to change the volume of the first reservoir in order to regulate the pressure in the vessel. Some syringe assembly embodiments include a plunger that is slidably connected to the housing. The plunger may include a distal seal that is configured to slide within the housing and thereby change the volume of the second reservoir. In some embodiments, when the adapter assembly and the syringe assembly are connected, the first reservoir is configured to deliver the flow of conditioning fluid to the medical vial and the second reservoir is It is configured to receive a flow of liquid from the vial.

In some embodiments, when the adapter assembly and the syringe assembly are not connected (eg, separated, separated, detached, separated, or otherwise), the first reservoir. And the second reservoir, respectively, are substantially sealed from the ambient environment and / or effectively sealed from the ambient environment. As used herein, the phrase "substantially sealed from the ambient environment" means preventing a stream of clinical purpose from flowing into the ambient environment during normal operating conditions. As used herein, the phrase "effectively sealed from the ambient environment" means preventing the formulation from moving into the ambient environment during normal operating conditions for normal operating hours.

Some embodiments have a conditioning channel that is configured to communicate the conditioning fluid from the first reservoir to the vial. Some embodiments include a first spring and an adjustment channel seal. The first spring may be configured to apply an axial force to press the adjustment channel seal against the sealing surface, thereby sealing the adjustment channel.

In some embodiments, the adapter assembly comprises a distally projecting penetrating member that is configured to allow fluid communication with the inner portion of the vial. The adapter assembly may include a proximally projecting member that is configured to compress the first spring to open the adjustment channel. The adapter assembly may include a passage that allows fluid communication with the inner portion of the vial. In some embodiments, the adapter assembly comprises a second spring that is axially connected to the adapter seal. The second spring may be configured to move the adapter seal to seal the passage in the adapter assembly. In some embodiments, the syringe assembly and the adapter assembly are configured to connect without requiring a particular direction of rotation of the syringe assembly relative to the adapter assembly.

In some embodiments, the syringe assembly is configured to regulate the pressure in the container. The syringe assembly may include a plunger comprising a first fluid reservoir capable of accommodating the pressure regulating gas. The syringe assembly may include a barrel comprising a second fluid reservoir capable of containing a liquid such as a medical liquid. The plunger can be slidably coupled to the barrel and can be configured to slide within at least a portion of the barrel. The syringe assembly may include a regulator channel that allows the first fluid reservoir to communicate with the vessel so that the syringe assembly can communicate the pressure regulating gas to regulate the pressure in the vessel. The syringe assembly can communicate the second fluid reservoir with the container so that the syringe assembly can withdraw the medical liquid from the container and move the medical liquid into the second fluid reservoir. It may include an extractor channel.

In some embodiments, the syringe assembly is configured such that the container of the first fluid reservoir does not necessarily change as the volume of the second fluid reservoir changes, which is the second fluid. This is because the reservoir is located in the barrel and the first fluid reservoir is located in the plunger. The syringe assembly may be configured such that the volume of the second fluid reservoir decreases as the plunger moves distally, but the volume of the first fluid reservoir does not necessarily change.

Any of the structures, materials, steps, or other features disclosed above or disclosed elsewhere herein can be used in any embodiment of this disclosure. Any structure, material, step, or other feature shown and / or described herein in combination with any other structure, material, step, or other feature shown and / or described herein. Can also be used.

Neither the outline of the invention described above nor the detailed description below do not limit or define the scope of protection. The scope of protection is defined by the claims.

The above-mentioned features and other features of the embodiments disclosed herein will be described below with reference to the drawings of each embodiment. The illustrated embodiment is merely an example and does not limit the embodiment. Although various structures, materials, steps, or other features of the disclosed embodiments may be combined to form additional embodiments, such embodiments are also part of the present disclosure.

It is a schematic diagram of the system for taking a fluid out of a container and / or injecting a fluid into a container. FIG. 5 is a schematic representation of another system for removing a fluid from a container and / or injecting a fluid into a container. FIG. 5 is a schematic representation of another system for removing a fluid from a container and / or injecting a fluid into a container. FIG. 6 is a schematic representation of another system for removing fluid from the container and / or injecting fluid into the container, with the reservoir in the retracted position. FIG. 5 is a schematic view of the system of FIG. 4 with the reservoir in the extended position. It is a side view of another system for taking a fluid out of a container and / or injecting a fluid into a container. It is a schematic diagram of the embodiment of the pressure adjusting syringe system connected to the container. FIG. 5 is a side sectional view of an embodiment of a pressure regulating syringe system connected to a container. It is a side view of the proximal plunger seal. It is sectional drawing which follows the line 10-10 of FIG. It is a side view of a plunger. It is sectional drawing which follows the line 12-12 of FIG. FIG. 5 is a side sectional view of an embodiment of a pressure regulating syringe system connected to a container. FIG. 5 is a side sectional view of an embodiment of a pressure regulating syringe system connected to a container. FIG. 5 is a side sectional view of an embodiment of a pressure regulating syringe system connected to a container. FIG. 5 is a side sectional view of an embodiment of a pressure adjusting syringe system. FIG. 16 is a side sectional view of the pressure adjusting syringe system of FIG. 16 connected to a container. FIG. 5 is a side sectional view of an embodiment of a pressure regulating syringe system including a bag. FIG. 5 is a perspective view of an embodiment of a pressure regulating syringe system in which at least a portion of the volume of the first reservoir is located radially outward from the second reservoir. It is a figure which illustrates the method for using a syringe system. It is a figure which illustrates the method for using a syringe system. It is a figure which illustrates the method for using a syringe system. It is a figure which illustrates the method for using a syringe system. It is a figure which illustrates the method for using a syringe system. FIG. 5 is a side sectional view of an embodiment of a pressure regulating syringe system including a coupling system. FIG. 5 illustrates an exemplary pressure regulating syringe system of FIG. 25, in which a syringe assembly is connected to an adapter assembly. FIG. 6 is a side sectional view of an embodiment of a pressure regulating syringe system in which a seal is arranged in a groove along an inner diameter. FIG. 6 is a side sectional view of an embodiment of a pressure regulating syringe system including a sealing gel. It is a perspective view of the syringe assembly including a plunger and a barrel. It is a perspective view of the syringe assembly including a plunger and a barrel. FIG. 9 is an assembled side view of the plunger of FIG. 29, including a proximal plunger seal, a distal plunger seal, a plunger body, and a grip. FIG. 9 is an exploded side view of the plunger of FIG. 29, including a proximal plunger seal, a distal plunger seal, a plunger body, and a grip. It is a side view of the proximal plunger seal of the plunger of FIG. 29B. It is a perspective view of the proximal plunger seal of the plunger of FIG. 29B. It is a perspective view of the proximal plunger seal of the plunger of FIG. 29B. It is a front view of the proximal plunger seal of the plunger of FIG. 29B. It is a side view of the distal plunger seal of the plunger of FIG. 29B. It is a perspective view of the distal plunger seal of the plunger of FIG. 29B. It is a perspective view of the distal plunger seal of the plunger of FIG. 29B. It is a front view of the distal plunger seal of the plunger of FIG. 29B. It is a perspective view of the plunger main body of the plunger of FIG. 29B. It is a perspective view of the plunger main body of the plunger of FIG. 29B. It is a perspective view of the grip of the plunger of FIG. 29B. It is a perspective view of the grip of the plunger of FIG. 29B. It is a side view of the barrel of the syringe assembly of FIG. It is an exploded perspective view of the barrel of FIG. 29P. It is an exploded side view of a part of the barrel of FIG. 29P. It is sectional drawing along the line 30-30 of FIG. FIG. 30 is a side sectional view of the syringe assembly of FIG. 30 in which the plunger is located proximal to the example of FIG. It is a perspective view of an adapter assembly. It is an exploded side view of the adapter assembly of FIG. 32 in the axial direction. It is a side view of a spring connected to a proximal shaft and a second seal. It is a top view of the adapter assembly of FIG. 32. It is sectional drawing along the line 36A-36A of FIG. FIG. 5 is a cross-sectional view in which the second seal is located proximally. FIG. 29 is a partially disassembled perspective view of the distal portion of the syringe assembly illustrated in FIG. It is a side sectional view of the distal part of a syringe assembly. It is a side sectional view of the distal part of a syringe assembly. It is a side sectional view of the syringe assembly of FIG. 29 connected to the adapter assembly of FIG. It is a figure which illustrates the distal part of the connected assembly of FIG. It is a figure which illustrates the syringe assembly of FIG. 41 that is mechanically and fluidly connected to the adapter assembly of FIG. 41. It is a figure which illustrates the syringe assembly of FIG. 41 which is mechanically and fluidly disconnected from the adapter assembly of FIG. 41. FIG. 4 is an approaching side view of the syringe assembly of FIG. 41, which is mechanically and fluidly connected to the adapter assembly. FIG. 4 is an approaching side view of the syringe assembly of FIG. 41, which is mechanically and fluidly disconnected from the adapter assembly. It is a figure which illustrates the method of fluid-connecting a syringe to an adapter. It is a figure which illustrates the method of fluidly disconnecting a syringe from an adapter. FIG. 3 is a perspective view of a pressure regulating syringe system just before the syringe assembly is connected to the adapter assembly. FIG. 5 is a cross-sectional perspective view taken along line 49-49 of FIG. 48 when the syringe assembly is fixed to the adapter assembly. FIG. 48 is a cross-sectional perspective view of the adapter assembly of FIG. 48 when the adapter assembly is not fixed to the syringe assembly and the distal plunger seal is moved to the distal position. FIG. 5 is a cross-sectional perspective view of the adapter assembly of FIG. 50 when the adapter assembly is fixed to the syringe assembly. It is a side sectional view of the syringe assembly which has a bag. It is a side sectional view of the syringe assembly which has a bag. FIG. 5 is a side sectional view of a pressure regulating syringe system with an auxiliary reservoir. It is a side sectional view of an auxiliary reservoir including a bag inside a rigid wall. It is a side sectional view of an auxiliary reservoir including a bag not surrounded by a wall. FIG. 5 is a side view of a seal having a rigid inner body and a compliant sealing member configured to fluidly seal the inner surface of the plunger. FIG. 5 is a side view of a seal having a rigid inner body and a compliant sealing member configured to fluidly seal the inner surface of the plunger. FIG. 5 is a side view of a seal having a rigid inner body and a compliant sealing member configured to fluidly seal the inner surface of the plunger. It is a side sectional view of a pressure adjustment syringe system. FIG. 6 illustrates the pressure regulating syringe system of FIG. 60 after the seal has moved distally and the plunger has moved proximally. It is a side sectional view of the syringe assembly and the connector of FIG. 38. It is a figure which illustrates the connector of FIG. 62 during the initial contact stage with a syringe assembly. It is a figure which illustrates the connector of FIG. 62 which is partially connected to a syringe assembly. It is a figure exemplifying the connector of FIG. 62 which is connected to a syringe assembly. It is a side view of the syringe assembly connected to the IV bag. It is a figure which illustrates the method of transferring a liquid from a 1st container to a 2nd container. It is a figure which illustrates the method of using a syringe assembly. FIG. 5 is a side sectional view of a syringe assembly, an adapter assembly, and a first container having a non-connected configuration. FIG. 6 is a side sectional view of an adapter assembly connected to the syringe assembly of FIG. 69 and connected to the first container. It is a side sectional view of the adapter assembly which is connected to a syringe assembly and is connected to a second container. FIG. 5 is a side sectional view of an adapter assembly removed from the syringe assembly after the syringe assembly has injected liquid into the second container. It is a side sectional view which collects a liquid preparation from a 2nd container into a 2nd reservoir. It is a side sectional view of the syringe assembly connected to the connector. It is a side sectional view of the syringe assembly which draws a fluid from a container. It is a side sectional view of the syringe assembly which draws a fluid from a container. It is a side sectional view of the syringe assembly which draws a fluid from a container. A schematic diagram of a fluid transfer assembly and an adapter assembly connected to a container assembly is illustrated. A schematic diagram of a fluid transfer assembly and an adapter assembly connected to a container assembly is illustrated. It is a side sectional view of the embodiment about the embodiment illustrated in FIGS. 76A and 76B. It is a side sectional view of the distal part of a syringe assembly just before connecting a syringe assembly with an adapter attached to a container. It is a side sectional view of the distal part of a syringe assembly just before the syringe assembly is fully connected with an adapter.

Although the present specification discloses certain embodiments and examples, the subject matter of the invention goes beyond the examples of the specifically disclosed embodiments to other alternative embodiments and / or uses, as well as modifications and equivalents thereof. It is expanded to things. Therefore, the scope of the claims attached herein is not limited to any of the specific embodiments described below. For example, in any of the methods or processes disclosed herein, the actions or actions of the methods or processes may be performed in any suitable order and are not necessarily limited to the particular order disclosed. The various actions may be described in sequence as multiple separate actions for ease of understanding of an embodiment, but the order in which they are described is understood to depend on such actions in that order. Should not be. The structures, systems, and / or devices described herein can be embodied as integrated components or as separate components. For the purpose of comparing various embodiments, certain aspects and advantages of these embodiments are described. Not all of these aspects or benefits are necessarily provided by any particular embodiment. Thus, for example, various embodiments achieve or achieve one or more of the benefits taught herein, without necessarily achieving other aspects or benefits that may also be taught or proposed herein. Can be performed to optimize. None of the features, benefits, benefits, structures, or steps disclosed herein are essential or essential.

The drawings illustrate certain embodiments and are not limiting. The drawings are schematic and may differ from the actual ratio. Some parts and / or dimensions in the drawings are greatly exaggerated for explicit presentation and discussion.

To explain, in the present specification, the term "horizontal" refers to the floor surface of the area where the described device is used or where the described method is performed, regardless of its orientation. Or it is defined as a plane parallel to the surface. The term "floor" is interchangeable with the term "ground". The term "vertical" refers to the direction perpendicular to the horizontal defined above. Terms such as "upper", "lower", "lower", "upper", "horizontal", "higher", "lower", "above", "above" and "below" are horizontal planes unless otherwise specified. It is defined for.

Various drugs and other therapeutic fluids are stored and distributed in drug vials or other containers of various shapes and sizes. These vials may be hermetically sealed to prevent contamination or leakage of stored fluids. The pressure difference between the inside of a sealed vial and a particular atmospheric pressure (where fluid is later removed) often causes various problems as well as the release of potentially harmful vapors. When used in the following embodiments, a "vial" can be any type of container used to store drugs, drugs, fluids used in medical care, or powders used in medical care.

For example, introducing a penetrating member of a vial adapter through a septum of a vial can increase (or possibly decrease) the pressure in the vial. This increased pressure can cause fluid to leak from the vial at the interface between the septum and the penetration member, or at the interface between the adapter and a medical device such as a syringe. Also, it can be difficult to draw the correct amount of fluid from a sealed vial using an empty syringe or other medical device. This is because when the syringe plunger is released, the fluid may naturally try to return into the vial. In addition, due to the pressure difference, a certain amount of fluid can be ejected from the syringe or vial as the syringe is disconnected from the vial.

In addition, in some examples, introducing fluid into a vial can increase the pressure in the vial. For example, in some cases it may be preferable to introduce a solvent (such as saline) into the vial to reconstitute the lyophilized formulation, for example in the vial. Due to the introduction of fluid into these vials, the pressure in the vial can be higher than the pressure in the ambient environment, resulting in the interface between the septum and the penetration member or the installation of medical devices such as adapters and syringes. At the interface, fluid may leak from the vial. In addition, the increased pressure in the vial can make it difficult to introduce the correct amount of fluid into the vial using a syringe or other medical device. Also, if the syringe is disconnected from the vial when the pressure in the vial is higher than the ambient pressure (eg atmospheric pressure), a portion of the fluid may spurt out of the vial due to the pressure gradient.

In addition, in some examples, air bubbles are drawn into the syringe as the fluid is drawn from the vial. Such bubbles are generally undesirable as they can also form embolisms when injected into the patient's body. To expel air bubbles from the syringe after pulling the syringe out of the vial, healthcare professionals may "flip" the syringe to collect all air bubbles near the opening of the syringe and then expel the air bubbles. This will usually also drain a small amount of liquid from the syringe. Healthcare professionals generally do not take additional steps to reconnect the syringe and vial until the air bubbles and fluid are expelled from the syringe. In some cases this may be prohibited by law and regulation. Such laws and regulations may also impose, in some cases, draining excess fluid somewhere outside the vial. Moreover, even if an attempt is made to reinsert additional air or fluid into the vial, it is sometimes possible that the amount of fluid collected will be inaccurate due to the pressure difference.

To address these problems caused by pressure differences, healthcare professionals often prefill empty syringes with an amount of ambient air that is exactly the amount of fluid they are trying to draw from the vial. is there. The healthcare professional then pierces the vial and expels the ambient air into the vial to temporarily increase the pressure in the vial. After that, when the desired amount of fluid is collected, the pressure difference between the inside of the syringe and the inside of the vial is almost in equilibrium. The volume of fluid can then be fine-tuned within the syringe to remove air bubbles without creating a clear pressure difference between the vial and the syringe. However, the major problem with this method is that the ambient air can contain various airborne viruses, bacteria, dust, spores, molds, and other unsanitary and harmful contaminants, especially in hospital environments. is there. The ambient air prefilled in the syringe may contain one or more of these harmful substances, which may then be mixed with the drug or other therapeutic fluid in the vial. When this contaminated fluid is injected directly into the patient's bloodstream, it can be particularly dangerous as it avoids many of the body's natural defenses against airborne pathogens. Moreover, patients in need of drugs or other therapeutic fluids are likely to have reduced immune defenses.

In the context of oncology and certain other drugs, all of the problems mentioned above can be particularly serious. Such drugs are useful when injected into the patient's bloodstream, but can be very harmful when inhaled or in contact. Therefore, it can be dangerous to eject such drugs out of the vial unpredictably due to pressure differences. In addition, these drugs are often volatile and can be aerosolized immediately upon exposure to ambient air. Therefore, expelling a small amount of such a drug to remove air bubbles or excess fluid from the syringe, especially under control, can repeat such actions many times daily. For healthcare professionals, it is generally not a viable option.

FIG. 1 is a schematic view of a container 10 such as a drug vial that can be connected to the accessor 20 and the regulator 30. In some configurations, the regulator 30 allows a portion or all of the contents of the container 10 to be removed via the accessor 20 without significantly changing the pressure in the container 10.

Generally, the container 10 is airtightly sealed so that the contents of the container 10 can be stored in a sterile environment. Container 10 can be deflated or pressurized after sealing. In some examples, the container 10 is partially or completely filled with a liquid such as a drug or other medical fluid. In such an example, one or more gases may also be sealed in the container 10. In some examples, a solid or powdered material, such as a lyophilized formulation, is placed in the container 10.

The accessor 20 can provide access to the contents so that the contents of the container 10 can be removed and added. In some configurations, the accessor 20 includes an opening between the inside and the outside of the container 10. The accessor 20 may have a passage between the inside and the outside of the container 10. In some configurations, the accessor 20 passage can be selectively opened and closed. In some configurations, the accessor 20 includes a conduit that extends through the surface of the container 10. The accessor 20 can be integrally formed with the container 10 before the container 10 is sealed, or can be introduced into the container 10 after the container 10 is sealed.

In some configurations, the accessor 20 is in fluid communication with the container 10, as indicated by the arrow 21. In some of these configurations, if the accessor 20 is introduced into the container 10 when the pressure in the container 10 is different from the pressure in the ambient environment, transfer through the accessor 20 occurs. For example, in some configurations, the pressure of the ambient environment of the container 10 is higher than the pressure inside the container 10, so that when the accessor 20 is inserted into the container 10, the ambient air of the environment enters from the accessor 20. is there. In other configurations, the pressure in the container 10 is higher than the pressure in the ambient environment so that the contents of the container 10 exit the accessor 20.

In some configurations, the accessor 20 is coupled to the replacement device 40. In one example, the accessor 20 and the replacement device 40 are separable. In some examples, the accessor 20 and the replacement device 40 are integrally formed. The switching device 40 is to receive the fluid and / or gas from the container 10 through the accessor 20, to introduce the fluid and / or gas into the container 10 through the accessor 20, or any combination of the two. It is configured to do. In some configurations, the replacement device 40 is in fluid communication with the accessor 20, as indicated by the arrow 24. In some configurations, the replacement device 40 includes a medical device such as a syringe or syringe assembly.

Continuing with reference to FIG. 1, in some examples, the replacement device 40 is configured to remove some or all of the contents of the container 10 via the accessor 20. In some configurations, the replacement device 40 can retrieve the contents regardless of the pressure difference between the inside of the container 10 and the surrounding environment, or even if there is no pressure difference. For example, if the pressure outside the container 10 is higher than the pressure inside the container 10, the replacement device 40 with the syringe can take out the contents of the container 10 when sufficient force is applied to pull the plunger from the syringe. Similarly, the exchange device 40 can introduce a fluid and / or gas into the container 10 regardless of the pressure difference between the inside of the container 10 and the surrounding environment.

In some configurations, the regulator 30 is connected to the container 10. The regulator 30 generally regulates the pressure in the container 10. As used herein, the term "adjusting" or any derivative thereof is a broad term used in its usual sense and, unless otherwise stated, any active, positive that tends to make a difference. , Or a positive effect, or any passive, responsive, reactive, receptive, or compensatory effect. In some examples, the regulator 30 substantially maintains a pressure difference or equilibrium between the interior of the vessel 10 and the ambient environment. As used herein, the term "maintain" or any derivative thereof is a broad term used in its usual sense, with slight variations that may be appropriate in the context. Also includes a tendency to preserve the original state for a period of time. In some examples, the regulator 30 keeps the pressure in the vessel 10 substantially constant. In one example, the pressure variation in the container 10 is about 1 psi or less, about 2 psi or less, about 3 psi or less, about 4 psi or less, or about 5 psi or less. In a further example, the regulator 30 equalizes the pressure exerted on the contents of the container 10. As used herein, the term "equalize" or any derivative thereof is a broad term used in its usual sense, with slight variations that may be appropriate in the context. It also includes a tendency to make the same amount or approach the same amount. In some configurations, the regulator 30 is coupled with the container 10 to allow equalization of the pressure difference between the inside of the container 10 and other environments such as the environment around the container 10 or the environment inside the exchange device 40. To encourage. In some configurations, one device includes a regulator 30 and an accessor 20. In other configurations, the regulator 30 and the accessor 20 are separate units.

As illustrated in FIG. 1, the regulator 30 generally communicates with the container 10 as indicated by arrow 31 and with the reservoir 50 as indicated by another arrow 35. In some configurations, the reservoir 50 comprises at least a portion of the ambient environment of the container 10. In some embodiments, the reservoir 50 is configured to vary in volume. In some practices, the reservoir 50 and the replacement device 40 are part of a medical device assembly, such as a pressure regulating syringe assembly. In some configurations, the reservoir 50 includes a chamber, container, canister, bag, or other container. As used herein, the term "bag" or any derivative thereof is a broad term used in its usual sense, for example, flexible, flexible, flexible, elastic, stretchable. And / or any bag, balloon, bladder, container, closed container, diaphragm, or membrane that can be expanded and / or contracted, including structures with expandable materials. In some embodiments, the reservoir 50 comprises a gas and / or liquid. As used herein, the term "flexible" or any derivative thereof is a broad term used in its usual sense, for example, fluid flowing into or container 10 (eg, via accessor 20). Represents the ability of a component to bend, expand, contract, fold, open, or otherwise substantially deform or change shape when flowing out of 10. Also herein, the term "rigidity" or any derivative thereof is a broad term used in its usual sense, for example, fluid flowing into or container 10 (eg, via accessor 20). It expresses the ability of a component to largely avoid substantial deformation during normal use, such as when flowing out of 10. In some embodiments, the reservoir 50 is bounded by at least one rigid wall. In one practice, the reservoir 50 is bounded by at least one movable wall. The volume of the reservoir 50 can change due to the movement of the movable wall.

In certain embodiments, the regulator 30 provides fluid communication between the container 10 and the reservoir 50. In some of such embodiments, the fluid in the reservoir 50 mainly contains a gas so as not to significantly dilute the liquid contents of the container 10. In some configurations, the regulator 30 includes a filter that purifies the gas or liquid entering the container 10 or removes contaminants, thus reducing the risk of contaminating the contents of the container 10. In some configurations, the filter is hydrophobic so that air can enter the vessel 10 but fluid cannot exit the vessel 10. In some configurations, the regulator 30 includes a directional activator or directional sensitive check valve that selectively blocks fluid communication between the vessel 10 and the filter. In some configurations, the regulator 30 includes a check valve, in which the valve and / or container 10 holds the regulator 30 above the regulator 30 (eg, farther from the floor than the regulator 30). When directed, it selectively blocks fluid communication between the vessel 10 and the filter.

In some embodiments, the regulator 30 prevents fluid communication between the container 10 and the reservoir 50. In some of such embodiments, the regulator 30 acts as an interface between the container 10 and the reservoir 50. In some configurations, the regulator 30 includes a substantially impermeable bag that accommodates entry of gas and / or liquid into container 10 or exit of gas and / or liquid container 10.

As schematically shown in FIG. 2, in certain embodiments, the accessor 20 or a portion thereof is disposed within the container 10. As described in detail above, the accessor 20 can be integrally formed with the container 10 or can be separated. In some embodiments, the regulator 30 or a portion thereof is located outside the container 10. In some configurations, the regulator 30 is integrally formed with the container 10. The accessor 20 or a portion thereof is completely inside, partially inside or outside the container 10, and / or the regulator 30 or a portion thereof is completely inside the container 10, partially inside. Any combination is possible, either on or outside.

In one embodiment, the accessor 20 is fluid connected to the container 10. In a further embodiment, the accessor 20 is in fluid communication with the switching device 40, as indicated by the arrow 24.

The regulator 30 may communicate with the container 10 in fluid or non-fluid communication. In some embodiments, the regulator 30 is located entirely outside the container 10. In certain embodiments, the regulator 30 includes a closure bag that is configured to expand or contract outside the container 10 to keep the pressure inside the container 10 substantially constant. In some variants, the regulator 30 includes a variable volume chamber (eg, bounded by at least one movable piston). In some embodiments, the regulator 30 communicates with the reservoir 50 in fluid or non-fluid communication, as indicated by arrow 35.

As schematically shown in FIG. 3, in certain embodiments, the accessor 20 or a portion thereof may be disposed within the container 10. In some embodiments, the accessor 20 or a portion thereof may be located outside the container 10. In some embodiments, the valve 25 or a portion thereof may be located outside the container 10. In some embodiments, the valve 25 or a portion thereof may be located within the container 10. In some embodiments, the regulator 30 is located completely outside the container 10. In some embodiments, the regulator 30 or a portion thereof may be located within the container 10. The accessor 20 or part thereof is completely inside, partially inside or outside the container 10, and / or the valve 25 or part thereof is completely inside the container 10, partially inside. Any combination is possible, either on or outside. Also, the accessor 20 or a portion thereof is completely inside, partially inside or outside the container 10, and / or the regulator 30 or a portion thereof is completely inside the container 10. Any combination is possible, either inside or outside.

The accessor 20 can communicate fluidly with the container 10 as indicated by the arrow 21. In some embodiments, the accessor 20 may have fluid communication with the switching device 40, as indicated by arrow 24.

In certain embodiments, the regulator 30 may communicate with the valve 25 in fluid or non-fluid communication, as indicated by arrow 32. In some embodiments, the valve 25 can be integrally formed with the container 10 or can be separated. In some embodiments, the valve 25 can be integrally formed with or separated from the regulator 30. In certain embodiments, the valve 25 may communicate with the vessel 10 in fluid or non-fluid communication, as indicated by arrow 33.

In some embodiments, the regulator 30 may have fluid or non-fluid communication with the ambient environment, as indicated by arrow 35A in FIG. In some embodiments, the regulator 30 may communicate with the reservoir 50 in fluid or non-fluid communication, as indicated by arrow 35B. In some embodiments, the reservoir 50 may include a bag or other flexible closed container. In some embodiments, the reservoir 50 includes a rigid container that surrounds the flexible closed container. In some embodiments, the reservoir 50 comprises a partially rigid closed container. In some embodiments, the reservoir 50 includes a closed container having a plurality of rigid walls and one movable member, and the internal volume of the reservoir 50 changes as the movable member moves.

According to some configurations, the regulator 30 may have a filter. In some embodiments, the filter may selectively block the passage of fluids, gases, liquids, and / or contaminants between the valve 25 and the reservoir 50 or the ambient environment. In some embodiments, the filter may selectively block the passage of fluids, gases, liquids, and / or contaminants between the reservoir 50 and the valve 25 and / or between the ambient environment and the valve 25.

In some embodiments, the valve 25 can be a check valve on the one hand. In some embodiments, the valve 25 can be a two-way valve. According to some configurations, the valve 25 may selectively block liquid, gas, and / or fluid communication between the filter and / or reservoir 50 and the vessel 10. In some embodiments, the valve 25 provides liquid, gas, and / or fluid communication between the container 10 and the filter and / or reservoir 50 when the container 10 is directed or placed above the replacement device 40. Can be selectively blocked.

As schematically illustrated in FIGS. 4 and 5, in certain embodiments, the reservoir 50 may be at least partially located within the regulator 30. The regulator 30 can communicate fluidly with the container 10 as indicated by arrows 32 and 33. In some embodiments, the valve 25 is located in the fluid path between the vessel 10 and the regulator 30. The regulator 30 may be configured to maintain a substantially constant pressure in the vessel 10 when the fluid is introduced into the vial 10 and / or when the fluid is drawn from the vial 10. For example, in some embodiments, the reservoir 50 is predominantly from an inner or contraction configuration (eg, as illustrated in FIG. 4) when fluid is added into the container 10 via the accessor 20 or otherwise. , (For example, as illustrated in FIG. 5), are primarily configured to transition to an outer or extended configuration. The reservoir 50 can be a flexible closed container such as a bag, or a variable volume rigid closed container such as a piston assembly (which may include a piston cylinder).

In some embodiments, the reservoir 50 is fully contained within the regulator 30 when the reservoir 50 is in a retracted configuration. In some embodiments, a cap or other enclosure structure can confine the reservoir 50 within the regulator 30. In some embodiments, the reservoir 50 is partially enclosed within the regulator 30. The enclosure structure and / or the regulator 30 can limit or prevent access to the reservoir 50 (eg, physical contact with the reservoir 50) when the reservoir 50 is in a retracted configuration.

In some embodiments, the volume of the reservoir 50 in the contracted configuration is significantly smaller than the volume of the container 10. For example, the volume of the contracted reservoir 50 can be about 20% or less of the volume in the container 10 and / or about 2% or more of the volume in the container 10. In some embodiments, the volume of the reservoir 50 in the contracted configuration is approximately 5% of the volume of the container 10. The volume of the portion of the regulator 30 that houses the contracted reservoir 50 can be approximately the same as the volume of the contracted reservoir 50. In some embodiments, the volume of the portion of the regulator 30 that houses the contracted reservoir 50 is greater than or equal to about 105% of the volume of the contracted reservoir 50 and / or less than about 120% of the volume of the contracted reservoir 50. Is.

When the reservoir 50 transitions to the expansion configuration, at least a portion of the reservoir 50 can expand out of the regulator 30. In some embodiments, as illustrated in FIG. 5, substantially all of the volumetric encircling area of the reservoir can move out of the regulator 30 and take a predominantly outer position. The volume of the reservoir 50 in this configuration can be significantly larger than the volume of the retractable reservoir 50. For example, the volume of the expansion reservoir 50 can be greater than or equal to about 15% of the volume of the vessel 10 and / or less than about 70% of the volume of the vessel 10. In some embodiments, the volume of the expanded reservoir 50 is approximately 50% of the volume of the container 10. Many variants are possible.

FIG. 6 illustrates an embodiment of a system 100 comprising a vial 110, an accessor 120, and a regulator 130. The vial 110 includes a body 112 and a cap 114. In an exemplary embodiment, the vial 110 contains a medical fluid 116 and a relatively small amount of sterile air 118. In some configurations, the fluid 116 is removed from the vial 110 when the vial 110 is oriented with the cap 114 facing down (eg, the cap 114 is between the fluid and the alcove). The accessor 120 includes a conduit 122 having one end fluidly connected to a replacement device 140 such as a syringe 142 having a plunger 144. The conduit 122 extends through the cap 114 into the fluid 116. The regulator 130 may include a reservoir 132 and a conduit 134. The reservoir 132 can be a chamber such as a bag or a cavity, which has a piston that is relatively movable relative to it. The reservoir 132 may be located, at least in part, inside the rigidly closed container 124.

The reservoir 132 and conduit 134 are in fluid communication with the reservoir interior 150, which contains a certain amount of clean and / or sterile air. In one embodiment, the reservoir 132 has a bag. In some embodiments, the reservoir 132 has one or more rigid walls and at least one movable wall 136. At least a portion of the outer surface of the reservoir 132 may come into contact with the ambient air surrounding the system 100. For example, the outer surface of the movable wall 136 may come into contact with ambient air. The reservoir 132 can be substantially impermeable so that the fluid 116, the air 118 in the vial 110, and the reservoir interior 150 do not come into contact with ambient air.

As shown in FIG. 6, the area outside the vial 110 is atmospheric pressure. Therefore, the pressure applied to the syringe plunger 144 is equal to the pressure applied to the inside of the reservoir 132, so that the system 100 is generally in equilibrium.

A part of the syringe 142 can be filled with the fluid 116 by pulling the plunger 144. Pulling the plunger 144 may increase the effective volume in the syringe 142, thereby reducing the pressure in the syringe 142. When the pressure drops in the syringe 142 in this way, the pressure difference between the inside of the vial 110 and the inside of the syringe 142 becomes large, and the fluid 116 flows into the syringe 142. As the fluid 116 flows from the vial 110 into the syringe 142, the pressure inside the vial 110 drops below the pressure inside the reservoir 150, which causes at least a portion of the reservoir inside 150 to flow into the vial 110. The flow from the vial 110 into the syringe 142 and from the reservoir inside 150 into the vial 110 continues until the pressure difference between the vial 110, the syringe 142, and the reservoir 150 becomes small and no flow occurs. .. The pressure difference required to create a flow depends on the viscosity of the flowing liquid (or gas) and the shape of the structure through which the fluid flows. Some embodiments have been optimized to reduce flow resistance.

As the pressure drops in the vial 110, the pressure difference between the inside and outside of the reservoir 132 increases, which reduces or contracts the internal volume of the reservoir 132, allowing a quantity of conditioning fluid to pass through the conduit 134 into the vial. Move to 110. That is, the reservoir 132 contracts outside the vial 110 to a new volume that compensates for the volume of fluid 116 taken from the vial 110. Therefore, when the plunger 144 is no longer pulled from the vial 110, the system is in equilibrium again. Since the system 100 operates in a state close to equilibrium, it may be easy to collect the fluid 116. In addition, the equilibrium of the system 100 allows the plunger 144 to remain in the pulled position, thereby removing the correct amount of fluid 116 from the vial 110.

In some configurations, the reduced volume of reservoir 132 is approximately equal to the volume of liquid removed from the vial 110. In some configurations, as more fluid is drawn from the vial 110, the volume of the reservoir 132 decreases at a slower rate, so the volume of fluid taken from the vial 110 is less than the reduced volume of the reservoir 132. Is also big.

In some configurations, the reservoir 132 is almost and / or completely collapsed or deflated, thus leaving little volume in the reservoir 132. For example, in an embodiment having a front side wall, a side wall, and a movable piston, the piston moves laterally to substantially abut the front side wall, thereby crushing the reservoir 132 and substantially eliminating the internal volume. be able to. In some examples, when the reservoir 132 collapses in this way, the reservoir 132 cannot allow the pressure in the vial 110 to reach ambient pressure. Therefore, when the reservoir 132 is completely collapsed, there may be negative pressure (relative to ambient pressure) in the vial 110. In some examples, such collapse of the reservoir 132 creates a pressure difference between the inside of the reservoir 132 and the inside of the vial 110, for example if the reservoir 132 is generally inelastic, rigid, or fully rigid. There is virtually no tendency for resilience.

Continuing with reference to FIG. 6, in one embodiment, the syringe 142 has a fluid content 143. A portion of the fluid content 143 can be introduced into the vial 110 by pushing the plunger 144 (towards the vial), which may be desirable in some cases. For example, in some cases it is desirable to introduce the solvent and / or mixing fluid into the vial 110. In some cases, more fluid 116 than originally expected may be unintentionally sampled. In some examples, a portion of the air 118 in the vial 110 may first be harvested and unwanted bubbles may be created in the syringe 142. Therefore, it may be desirable to inject the collected fluid 116 and / or air 118 back into the vial 110.

When the plunger 144 is pushed, the fluid content 143 of the syringe enters the vial 110, reducing the effective volume of the vial 110 and thus increasing the pressure in the vial 110. When the pressure in the vial 110 increases, the pressure difference between the inside of the vial 110 and the inside of the reservoir 132 increases, air 118 can flow into the reservoir 132, and the reservoir 132 expands. That is, the reservoir 132 expands or expands to a new volume that compensates for the volume of the contents 143 of the syringe 142 introduced into the vial 110. Therefore, when the plunger 144 stops moving towards the vial 110, the system is in equilibrium again. Since the system 100 operates in a state close to equilibrium, the introduction of the contents 143 may be facilitated. In addition, the equilibrium of the system 100 allows the plunger 144 to remain approximately in the pressed position, thereby introducing the exact amount of the contents 143 of the syringe 142 into the vial 110.

If the pressure in the syringe 142 is greater than or equal to the pressure in the vial 110, the plunger 144 can move abruptly if the pressure difference is greater than the frictional force. In some embodiments, a temporary pressure difference is utilized, for example, to prevent fluid from dripping from the syringe after removing the syringe from the vial. For example, the effective volume of a portion of the syringe can be increased, thereby reducing the local pressure and drawing at least some fluid into the area of increased volume. However, some embodiments minimize the temporary pressure difference.

In some configurations, the increased volume of reservoir 132 is approximately equal to the volume of air 118 removed from the vial 110. In some configurations, as more contents 143 are introduced into the vial 110, the volume of the reservoir 132 increases at a slower rate, so the volume of the contents 143 introduced into the vial 110 increases. It is larger than the volume of 132.

In some configurations, the reservoir 132 can be extended, expanded, or otherwise increased in volume to expand beyond the rest volume. In some examples, this expansion provides a restoring force that effectively creates a pressure difference between the interior of the reservoir 132 and the interior of the vial 110. For example, expansion or expansion of the reservoir 132 can create a slight overpressure (relative to ambient pressure) in the vial 110.

Many of the components described herein can be molded as individual components and / or can be integrated with other molded components. For example, in some cases, a plurality of components can be simultaneously molded in a single molding press. Some of the components can be injection molded using medical grade plastics. Some components are made from acrylic plastic, ABS plastic, or polycarbonate plastic. Some components can be made from metals such as stainless steel. Many of the metal components can be machined using a computer numerically controlled (CNC) mill.

Expansion reservoirs, such as certain bags, may be configured to open, expand, expand, contract, bulge, deflate, compress, and / or restore (decompressed). The reservoir can contain any of any kind of flexible and / or expandable material (although some reservoirs are inflexible and rigid). For example, in certain embodiments, the reservoir or bag comprises polyester, polyethylene, polypropylene, saran, latex rubber, polyisoprene, silicone rubber, vinyl, polyurethane, or other material. In certain embodiments, the reservoir or bag is a material having metal components to further prevent fluid (including gas or air) from leaking from the bag material, such as metallized biaxially stretched polyethylene terephthalate (“PET””. Also known as, and includes the trade name Mylar® (available as a registered trademark). In some embodiments, the reservoir and bag include a laminate. Reservoir and bag may contain metallic material. For example, the reservoir and bag may consist of a 0.36 mil (7.8 #) metallized (eg aluminum) PET film layer and a 0.65 mil (9.4 #) linear low density polyethylene layer. In some embodiments, the reservoir or bag comprises a material capable of forming a substantially airtight seal using a connector. In certain embodiments, the reservoir and bag are transparent or substantially transparent. In other embodiments, the reservoir and bag are opaque. In some examples, reservoirs and bags contain materials that are generally impermeable to liquids, gases, and air (for at least a sufficient period of time under normal use conditions). In certain embodiments, the reservoir and bag contain a material that is inert to the intended contents of the vial. For example, in some cases, reservoirs and bags contain materials that do not respond to certain drugs used in chemotherapy. In some embodiments, the reservoir and bag comprise a latex-free silicone having a hardness of about 10 shore A or greater and / or about 80 shore A or less.

In some configurations, the reservoir contains a coating. For example, in some embodiments, the reservoir comprises a coating that reduces its pore space. In some cases, the coating is thin-filmed aluminum or gold. In some cases, the coating comprises a water-soluble plastic that is configured to form a barrier that blocks the passage of gas. In one example, the coating is applied to the outside of the reservoir. In another example, the coating is applied to the inside of the reservoir. In some cases, the coating is applied to the inside and outside of the reservoir. In some embodiments, the coating is polyolefin.

The vial can contain any suitable container for storing the medical fluid. For example, the vial can be any of the many standard medical vials known in the art, such as those manufactured by Abbott Laboratories in Abbott Park, Illinois. In some embodiments, the vial can be hermetically sealed. In some configurations, the vial has a body and a cap. The body can be a rigid, substantially impermeable material, such as plastic or glass. In some embodiments, the cap may include a septum and a casing. The septum can be an elastomeric material that can be deformed to form a substantially airtight seal around the article when penetrated by the article. For example, in some examples, septum comprises silicone rubber or butyl rubber. The casing can be any suitable material that seals the vial. In some examples, the casing contains a metal that is crimped around the septum and part of the body to form a substantially airtight seal between the septum and the vial. In certain embodiments, the cap has a ridge extending outward from the top of the body.

As detailed below, some embodiments include a seal. The seal can be formed (eg molded) with a medical grade silicone having a hardness of 35 shore A to 90 shore A. Other seals and components are molded from other flexible or semi-flexible materials.

One embodiment includes a filter capable of removing passing gaseous particles and / or contaminants. For example, in one embodiment, the filter is configured to remove almost all or at least 99.9% of airborne particles with a diameter of 0.3 micromillimeters. In some cases, the filter is configured to remove microorganisms. In some embodiments, the filter comprises nylon, polypropylene, polyvinylidene fluoride, polytetrafluoroethylene, or other plastic. In some embodiments, the filter comprises activated carbon, such as activated charcoal. In some configurations, the filter comprises a regularly or randomly arranged fiber, such as a glass fiber mat. In some configurations, the filter comprises a Gore-Tex® material or a Teflon® material.

In some embodiments, the filler is placed in a reservoir such as a bag. In some embodiments, at ambient pressure, the diameter and thickness of the filler is approximately the same as the diameter D and thickness T of the bag. In some configurations, the filler is configured to contain a certain amount of gas, such as sterile air. In some cases, the filler is porous. In some examples, the filler is a sponge or sponge-like material. In some configurations, the filler comprises cotton padding. In some configurations, the filler comprises a regularly or randomly arranged fiber mat that is configured to provide a network of chambers or spaces within. In some embodiments, the filler is made of low density foam. For example, in one embodiment, the filler is made of polyurethane-ether foam, weighs, for example, about 1.05 lbs / cubic foot, and the indentation load (“ILD”) is, for example, about 38. In some embodiments, the filler is made of polyether, polyester, polyethylene, or ether-like-ester (“ELE”). In some cases, the filler is made of nylon, polypropylene, polyvinylidene fluoride, polytetrafluoroethylene, or other plastic. In certain embodiments, the filler is a metal, for example aluminum or stainless steel. In certain embodiments, the filler is treated with an antibacterial agent or other sterility-enhancing compound. In some cases, the filler has a sealed chamber that houses, for example, sterile air, which chamber is configured to open when the fluid is drawn from the vial. In some embodiments, the filler binds to a fluid (such as vapor) that enters the bag, absorbs the fluid, largely neutralizes it, or otherwise interacts chemically and / or mechanically with the fluid. Can be configured in.

FIG. 7 schematically illustrates an embodiment of a pressure regulating syringe system 200 connected to a container 204 such as a vial. Container 204 may be configured to contain drugs, formulations, and / or substances used in medical care. The conditioning system 200 may include a first reservoir 208 and a second reservoir 212. The first reservoir 208 and the second reservoir 212 may be configured to vary in volume (eg, individually and / or together). In some embodiments, the first reservoir 208 is configured to store a gas, which can be sterile air, non-sterile air, or any gas. In some embodiments, the second reservoir 212 is configured to store a liquid, which is a drug fluid, any fluid containing a pharmaceutical, a liquid injected into a container 204, water, and the like. It can be saline, or any liquid. The first reservoir 208 and the second reservoir 212 may be located within a housing, which housing may include a barrel and / or a plunger. The housing is low brittle to prevent cracking and can be substantially rigid. In some embodiments, the housing is made from molded plastic. This plastic can be transparent and / or translucent. In any of the embodiments herein, as illustrated, the first and second reservoirs allow fluid to flow directly between the first and second reservoirs (eg, the first reservoir) during use. It may be configured so that it does not pass directly from the reservoir to the second reservoir, or from the second reservoir to the first reservoir).

In many embodiments described herein, containers 204, 304 are packages, bags, containers (bins) configured to contain vials, plastic vials, glass vials, ampoules, cubets, and agents. , Bottles, bowls, canisters, cartons, flasks, containers (jugs), packets, parcels, containers, bags, drug storage devices, fluid storage devices, drug containers, drug containers, test tubes, tubes, cannulas, and fluids. May include a tank.

In some embodiments, the first reservoir 208 and / or the second reservoir comprises a bag having an internal volume. The internal volume can increase or decrease. In some embodiments, the first reservoir 208 and / or the second reservoir has a rigid outer housing that can be made of plastic. The rigid outer housing may be somewhat flexible if it is subjected to sufficient force or pressure.

As schematically illustrated in FIG. 7, certain embodiments include a split member such as a seal 216. The seal 216 may be placed between the first reservoir 208 and the second reservoir 212. The seal 216 can isolate the first reservoir 208 from the second reservoir 212 (eg, fluidly isolate), and the liquid or gas located in the first reservoir 208 interferes with the seal 216. Prevents or prevents the flow of liquid or gas into the second reservoir 212 through the area of the second reservoir 212, and the first liquid or gas located in the second reservoir 212 passes through the area obstructed by the seal 216. Blocks or prevents flow into reservoir 208. In some embodiments, the seal is a rubber plunger seal or a rubber O-ring.

Some embodiments include a first passage 220 (eg, passage, channel, lumen, or other). Since the first passage 220 can fluidly connect the first reservoir 208 to the container 204, the fluid and / or gas of the first reservoir 208 can flow into the container 204 and / or the fluid and / or gas of the container 204. Can flow into the first reservoir 208.

Some embodiments include a second passage 224 (eg, passage, channel, lumen, or other). Since the second passage 224 can fluidly connect the second reservoir 212 to the container 204, the fluid and / or gas of the second reservoir 212 can flow into the container 204 and / or the fluid and / or gas of the container 204. Can flow into the second reservoir 212. The first passage 220 and the second passage 224 may include lumens, channels, open areas, or any other structure capable of forming passages capable of containing or communicating fluids, liquids, and / or gases. .. In various embodiments, the first passage 220 is referred to as the "coordination channel" and the second passage 224 is referred to as the "access channel" or "pull-out channel".

In some embodiments, the second passage 224 is an extractor channel configured to communicate liquids, drug solutions, medical liquids, drug fluids, and / or saline. In some embodiments, the second passage 224 is configured to communicate gas, sterilized gas, and / or air. In some embodiments, the first passage 220 is a regulator channel configured to regulate the pressure in the vessel 204. In some embodiments, the first passage 220 is configured to communicate gas, sterilized gas, and / or air. In some embodiments, the first passage 220 is configured to communicate a liquid, a drug solution, a medical liquid, a drug fluid, and / or a saline solution. In some embodiments, the first passage 220 and / or the second passage 224 is configured to communicate powders such as medical powders.

Continuing with reference to FIG. 7, some embodiments include a first flow control unit 228. When in the open position, the first flow control unit 228 allows the fluid to flow through the first passage 220. When in the closed position, the first flow control unit 228 blocks or prevents fluid from flowing through the first passage 220. One embodiment has a second flow control unit 232. When the second flow control unit 232 is in the open position, the fluid can flow through the second passage 224. When the second flow control unit 232 is in the closed position, the fluid is blocked or prevented from flowing through the second passage 224. In some embodiments, the first flow control unit 228 and the second flow control unit 232 are one flow control unit, so that one flow control unit is used in the first passage 220 and in the second passage 224. The flow of liquid and / or gas can be controlled. Some embodiments of the flow control unit include a seal that opens and closes the passage. The first flow control unit 228 and / or the second flow control unit 232 are pump assembly, valve assembly, sealing assembly, seal assembly, and / or pumping discharge and / or selectively sealing. And / or may include them. In some embodiments, the first flow control unit 228 and / or the second flow control unit 232 is a valve, the valve having an open position for passing fluid through the valve and the valve. It has a closed position that substantially blocks the passage of fluid.

The first passage 220 may be located outside the first reservoir 208 and the second reservoir 212. The first reservoir 208 may have a central axis that is approximately parallel to the longitudinal axis of the system 200. In some embodiments, the first passage 220 and / or a portion of the first passage 220 may be located radially outward from the central axis of the first reservoir 208. The first passage may be located radially outside the first reservoir 208, rather than inside the outer perimeter of the first reservoir 208.

Some embodiments include a pressure regulator 240. The pressure regulator 240 may be configured to reduce and / or eliminate the pressure difference between the pressure of ambient air 244 (outside the pressure regulating syringe system 200) and the pressure in the first reservoir 208. In various embodiments, the pressure regulator 240 can equalize the pressure in the first reservoir 208 with the ambient air 244 (eg, the pressure regulator 240 can be a pressure equalizer in some embodiments). .. In some embodiments, the pressure regulator 240 may be prevented from equalizing the pressure between the ambient air 244 and the first reservoir 208 by friction or cracking pressure. The pressure regulator 240 can be lubricated (eg with a medical grade lubricant) to reduce friction and / or cracking pressure, thereby increasing the equalizing capacity of the pressure regulator 240. The pressure regulator 240 may be a component that changes the effective volume of the first reservoir 208. In some embodiments, the pressure regulator 240 is a bag. In some embodiments, the first reservoir 208 has an open end sealed with a rubber plunger and the pressure regulator 240 slides within the first reservoir 208 of the first reservoir 208. Includes the rubber plunger that changes the effective internal volume. The pressure regulator 240 may be a component that allows ambient air 244 to flow into or out of the first reservoir 208. In various implementations, the pressure regulator 240 may include a hole that can be covered with a valve or cap (eg, opened by a pressure difference).

In FIG. 7, ambient air 244 is shown by a cloud with a dashed line surrounding the pressure regulating syringe system 200. This indicates that the ambient air 244 typically surrounds the pressure regulating syringe system 200. Many other figures shown herein include ambient air surrounding each embodiment, but many figures do not include a dashed box to clearly indicate other articles. Ambient air is typically outside the pressure regulating syringe system and typically surrounds the pressure regulating syringe system.

Some embodiments include a coupling system 250 that fluidly and / or mechanically connects the pressure regulating system 200 to the container 204, the container 204 being a vial, a glass container, a rigid plastic container, a flexible plastic container, It can be any container used for intravenous infusion, or any other container. In some embodiments, the first flow control unit 228 and the second flow control unit 232 are part of the coupling system 250. In some embodiments, the first flow control unit 228 and / or the second flow control unit 232 go from a closed position to an open position while the pressure adjusting syringe system 200 is connected to the vessel 204.

In some embodiments, the first reservoir 208 and the second reservoir 212 are part of a closed system that is fluidly isolated from the ambient air 244. The closed system can help limit and / or prevent the amount of medicinal release from the pressure regulated syringe system 200 into the ambient air 244. The pressure regulating syringe system 200 may be configured to prevent liquids and gases contaminated with the formulation from the container 204 from exiting the pressure regulating syringe system 200. The first flow control unit 228 and the second flow control unit 232 allow gas and liquid to flow from the first reservoir 208 and / or the second reservoir 212 after the pressure regulating syringe system 200 is disconnected from the container 204. It may be configured to prevent and / or limit leakage.

In some embodiments, the first reservoir 208 and the second reservoir 212 are located outside the container 204, which can be a vial. The first reservoir 208 and the second reservoir 212 may be integrated within the syringe and / or placed within the syringe. In some embodiments, the first reservoir 208 is located within the plunger of the syringe and the second reservoir is located within the barrel of the syringe. The barrel can be a housing into which the plunger can slide. The plunger may constitute some of the outer walls of the first reservoir 208. In some embodiments, the plunger may constitute one or more walls of the second reservoir 212. The barrel may form some of the outer walls of the second reservoir 212.

FIG. 8 illustrates a cross-sectional view of another embodiment of the pressure regulating syringe system 300 connected to a container 304 such as a vial. The system 300 may be the same as or identical to any of the other pressure regulating syringe systems described herein and may include any of the features of such other systems. The cross section illustrated in FIG. 8 is along the central axis of the pressure regulating syringe system 300. As shown, the system 300 may include a syringe assembly 301 and a coupling system 354.

The coupling system 350 includes an arm 354 configured to be attached to the container 304 by engagement (eg, snap fitting) with the neck 358 of the container 304. The arm 354 can flex outward in the radial direction as it slides over the lip 362 of the container 304 and then inwardly when mating with the neck 358 of the container. In some embodiments, the diameter of the neck 358 is smaller than the diameter of the lip 362. Container 304 can be a glass vial, a plastic vial, or any other container. In various embodiments, the syringe assembly 301 may be detachably coupled to the coupling system 354.

The container 304 may include a septum 370 and / or a lip 362 of the neck 358 that is configured to prevent the gas or liquid from being accidentally delivered. The septum 370 can prevent the ambient air 244 from accidentally entering the container 304, and can prevent the gas or liquid arranged in the container 304 from accidentally leaving the container. Since the first passage 320 and the second passage 324 can pass (ie, penetrate) the septum 370, gas and fluid can be transferred to and / or from the container 304.

A portion of the first passage 320 configured to pass through the septum 370 may be located within the first penetration member 374. A portion of a second passage 324 configured to pass through the septum 370 may be placed within the second penetration member 378. In some embodiments, the first penetration member 374 and the second penetration member 378 are part of one penetration member. For example, the penetration member can be a plastic lance that includes a portion of the first passage 320 and a portion of the second passage 324. In some practices, the lance has a pointed distal tip. In some variants, the lance has a generally rounded distal tip. The distal end 382 of the first passage 320 is the first penetrating member 374 at the distal end of the first penetrating member 374 or within about 1 cm from the distal end of the first penetrating member 374. You can get out of. The distal end 386 of the second passage 324 is at the distal end of the second penetrating member 378, or within about 1 cm from the distal end of the second penetrating member 378, the second penetrating member 378. You can get out of.

As illustrated in FIG. 8, the syringe system 300 may include a barrel 390 and a plunger 394. The barrel 390 may be a housing or conduit to which the plunger 394 is slidably connected. The plunger 394 can move distally and proximally relative to the barrel 390. As used herein, the term "distal" or any derivative thereof is directed along the axial length of the syringe system toward the end of the syringe system that engages the container, such as the vial 304. Means. The term "proximal" or any derivative thereof means the opposite direction, which is usually towards the user holding a portion of the syringe assembly. For example, in FIG. 8, the plunger 394 is located relative to the vial 304 and the vial 304 is located relatively distal to the plunger 394.

The distal plunger seal 316 may be connected to the distal end of the plunger 394. In some embodiments, the volume of the second reservoir 312 is the internal space of the barrel 390 up to the distal plunger seal 316. The syringe system 300 may be configured to reduce the volume of the second reservoir 312 by pushing the plunger 394 distally (eg, towards container 304). The distal plunger seal 316 can be a double wiper seal and can be made of rubber. Pushing the plunger 394 distally allows gas or liquid located in the second reservoir 312 to flow into the container 304 through the second passage 324.

The barrel 390 and the plunger 394 can have various shapes and sizes. In some embodiments, the barrel 390 and the plunger are generally cylindrical and have a generally circular cross section. In some embodiments, the barrel 390 and the plunger 394 have a generally rectangular cross section with rounded corners for easy sealing. In some embodiments, the barrel 390 and the plunger 394 are sized and shaped such that the barrel 390 can receive the plunger 394.

In some embodiments, the internal volume of the plunger 394 is at least about 40 milliliters and / or about 100 milliliters or less, at least about 10 milliliters and / or about 300 milliliters or less, or at least about 55 milliliters and / or about 85 milliliters. It is as follows. In some embodiments, the internal volume and / or maximum internal volume of the first reservoir 308 (which can be a gas reservoir) is at least about 40 milliliters and / or about 100 milliliters or less, at least about 10 milliliters and / or about. 500 ml or less, or at least about 55 ml and / or about 85 ml or less.

In some embodiments, the internal volume of the barrel 390 is at least about 40 milliliters and / or about 100 milliliters or less, at least about 10 milliliters and / or about 300 milliliters or less, or at least about 55 milliliters and / or about 85 milliliters. It is as follows. In some embodiments, the internal volume and / or maximum internal volume of the second reservoir 312 (which may be configured to contain the liquid) is at least about 40 milliliters and / or about 100 milliliters or less, at least about 10 milliliters. And / or about 500 milliliters or less, or at least about 55 milliliters and / or about 85 milliliters or less.

In some embodiments, the capacity of the second reservoir 312 is greater than or equal to about 60 milliliters and the capacity of the first reservoir 308 is greater than or equal to 70 milliliters. The maximum capacity of the first reservoir 308 is greater than the maximum capacity of the second reservoir 312.

In some embodiments, the first reservoir 308 contains a sterile gas, such as sterile air. The first reservoir 308 is fluidly isolated (eg, sealed) from the ambient air 244 so that the pressure regulating syringe system 300 prevents and / or interferes with gas exchange between the first reservoir 308 and the ambient air 244. Can be done. The second reservoir 312 may be configured to contain the pharmaceutical substance.

In some embodiments, the volume of the first reservoir 308 is the volume within the plunger 394 from the distal plunger seal 316 to the proximal plunger seal 340. The distal plunger seal 316 can separate the first reservoir 308 from the second reservoir 312. The proximal plunger seal 340 can be a double wiper seal and can be made of rubber. The first reservoir 308 can communicate fluidly with the first passage 320. When the syringe assembly 301 is connected to the connecting assembly 354 and the connecting assembly 354 is connected to the container 304, the gas or other fluid disposed in the first reservoir 308 is inside the first reservoir 308 and the container 304. Can flow between. The gas or fluid can flow from the container 304 to the first reservoir 308. Some embodiments include a valve that obstructs the flow from container 304 to the first reservoir 308 or obstructs the flow from the first reservoir 308 to container 304. In some embodiments, the first reservoir 308 is in fluid communication with the inner portion of the container 304.

The proximal plunger seal 340 may be located within the plunger 394 and may be slidably coupled within the plunger 394. The proximal plunger seal 340 can separate the distal gas reservoir from the proximal gas reservoir. The distal gas reservoir may be located distal to the proximal plunger seal 340, and the proximal gas reservoir may be located proximal to the proximal plunger seal 340. In some embodiments, the proximal gas reservoir may contain a portion of the surrounding ambient air. The proximal plunger seal 340 can be sealed against the inner diameter of the plunger 394. The plunger 394 may be slidably connected to the barrel 390. The proximal plunger seal 340 may be configured to move (eg, slide) within the plunger 394 depending on the pressure difference between the distal gas reservoir and the proximal gas reservoir. In some variants, the proximal gas reservoir is fluid connected to the ambient air 244. In some embodiments, the pressure in the proximal gas reservoir is ambient pressure.

As shown in FIG. 8, some embodiments include a second reservoir 312. The second reservoir 312 may be configured to contain the liquid. The second reservoir 312 may be located relative to the distal gas reservoir of the plunger and / or distal to the distal plunger seal 316. The second reservoir 312 may be located within the barrel 390. In some variants, the second reservoir 312 is the volume bounded by the barrel 390, the distal plunger seal 316, and the distal wall of the syringe assembly 301.

In some embodiments, the syringe system has an area 398 between barrel 390 and plunger 394. This area may be located radially outward from the plunger 394 and radially inward from the barrel 390. Proximal seals 406, such as O-rings, can prevent or prevent gas or liquid from exiting area 398 into ambient air 244. In some embodiments, the proximal seal 406 may be located near the finger grip 402 of the barrel. For example, when measured parallel to the longitudinal axis of the system 300, the proximal seal 406 is at least about 0.01 cm and / or about 1 cm or less from the finger grip 402 of the barrel, or the finger grip of the barrel. It can be at least about 0.1 cm and / or less than about 4 cm from 402.

In some embodiments, the proximal end of the first passage 320 may be located near the finger grip 402 of the barrel, at least about 0.01 cm and / or about 1 from the finger grip 402 of the barrel. It can be located no more than a centimeter, or at least about 0.1 centimeter and / or about 4 centimeters or less from the finger grip 402 of the barrel. Air or gas disposed within the first reservoir 308 can flow from the hole 410 of the first reservoir 308 (eg, the hole of the plunger 394) through area 398 to the proximal end of the first passage 320. In some embodiments, the gas or fluid passing through the area 398 flows in one direction and the gas passing through the first passage 320 flows in the opposite direction.

As shown in FIG. 8, area 398 may border a passage between a portion of barrel 390 and a portion of plunger 394. The passage bounded by the area 398 may be oriented substantially parallel to a portion of the first passage 320. A portion of the first passage 320 may be located radially outward relative to area 398. A portion of the first passage 320 may be located radially outside and / or outside of the plunger 394, the first reservoir 308, the second reservoir 312, and / or the barrel 390. In some embodiments, a portion of the first passage is located inside the plunger 394 rather than radially outside the plunger 394.

The plunger 394 may have a finger grip 414. In some embodiments, the user pulls the plunger finger grip 414 (eg, away from the barrel finger grip 402), thereby increasing the capacity of the second reservoir 312 and allowing the liquid to be placed in the container 304. Can be withdrawn from the second passage 324 to the second reservoir 312. When the liquid is withdrawn from the container 304, the pressure inside the container 304 can be lower than the ambient pressure (eg, the pressure of the external environment of the syringe system 300). When the pressure in the container 304 drops below the ambient pressure, the gas in the first reservoir 308 flows into the first passage 320 and then into the container 304, increasing the pressure in the container 304 to the ambient pressure. Can be made to. When the gas in the first reservoir 308 is taken out in this way, the pressure in the first reservoir 308 can be lower than the ambient pressure. Therefore, some embodiments include pressure equalization devices to address this situation and / or other pressure imbalances.

As illustrated in FIG. 8, some embodiments include a proximal plunger seal 340 that can move axially within the plunger 394. The plunger 394 may include a vent 420 that allows ambient air to enter a portion of the plunger 394 up to the proximal plunger seal 340. The proximal plunger seal 340 may be configured to prevent and / or reduce the flow of ambient air entering the first reservoir 308. For example, the proximal plunger seal 340 can form a generally airtight seal with the inner wall of the plunger 394. The proximal plunger seal 340 may be configured to prevent and / or reduce the flow of gas from within the first reservoir 308 to the surrounding environment.

In various embodiments, the proximal plunger seal 340 facilitates pressure equalization of the first reservoir 308 and ambient air 244 and / or reduces the pressure difference. If the ambient pressure is higher than the pressure in the first reservoir 308, the proximal plunger seal 340 may move distally due to the pressure difference. For example, the proximal plunger seal 340 reduces the pressure difference until the pressure difference disappears or decreases, for example, the proximal plunger seal 340 cannot overcome other forces (such as frictional forces) that move it. Can move distally until If the ambient pressure is lower than the pressure in the first reservoir 308, the proximal plunger seal 340 may move proximally due to the pressure difference. For example, the proximal plunger seal 340 reduces the pressure difference to the point that it cannot overcome other forces (such as frictional forces) that move the proximal plunger seal 340, for example, until the pressure difference disappears or decreases. Can move proximally until

9 and 10 illustrate side views and cross-sectional views of the proximal plunger seal 340. As shown, the proximal plunger seal 340 may include a sealing member 430 and a support member 434. The sealing member 430 may include one or more sealing surfaces 438, such as a wiper seal or O-ring. The sealing surface can be made from a flexible or semi-flexible material configured to seal the proximal end of the first reservoir 308 (shown in FIG. 8). At least a portion of the sealing member 430 may be located radially outward from at least a portion of the support member 434. As shown, in some embodiments, at least a portion of the proximal plunger seal 340 (eg, support member 434) is hollow. In any embodiment of the present specification, as illustrated, in any plunger seal of any type, to prevent fluid from passing directly from the proximal side to the distal side of the plunger seal, or to prevent fluid from passing through the plunger seal. To, or as the plunger seal is permanently closed to the fluid passage, or as the plunger seal is valveless, or the fluid passes through the plunger seal from the first reservoir of the syringe to the second reservoir of the syringe. It can be configured so that it cannot pass through.

In some embodiments, the sealing member 430 is made of medical grade silicone rubber with a hardness of about 35 shore A to about 95 shore A. In some embodiments, the sealing member 430 has a hardness of at least about 35 shore A and / or about 95 shore A or less, at least about 45 shore A and / or about 85 shore A or less, or at least about 55 shore A. And / or includes materials of about 80 Shore A or less. Some proximal plunger seal embodiments are made entirely or partially of rubber. Some proximal plunger seal embodiments include non-rubber materials such as thermoplastics.

One embodiment is configured to prevent or prevent the sealing member 430 (eg, at least a portion of the proximal plunger seal 340) from tilting, squeezing, breaking, or otherwise losing contact with the inside of the plunger 394. (Shown in FIG. 8) to assist in maintaining proper sealing. The support member 434 may be made of a material that is less flexible than the material used to make the sealing member 430. The support member 434 can be made of a material that is harder than the material used to make the sealing member 430. In some embodiments, the support member 434 has a hardness of at least about 40 shore D and / or about 95 shore D or less, at least about 55 shore D and / or about 85 shore D or less, or at least about 65 shore D and / Or includes materials of about 75 Shore D or less.

The support member 434 can be molded from rigid plastic and the sealing member 430 can be molded from a compliant rubber such as medical grade silicone. The sealing member 430 may be connected to the distal or proximal end of the support member 434. The outer diameter of the sealing surface 428 can be larger than the outer diameter of the support member 434.

11 and 12 illustrate side views and cross-sectional views of a plunger 450 (eg, tube, actuator, shaft, etc.) that may be part or all of the disclosed syringe assembly. The plunger 450 allows the user to push the plunger 450 at least partially distally into the barrel (eg, housing, casing, closed container, etc.) and pull the plunger 450 at least partially proximally out of the barrel. Can include a finger grip 454. The plunger 450 may include a vent 456, whereby ambient air enters the proximal portion 458 of the plunger 450 and moves the proximal plunger seal 460 distally or proximally within the plunger 450 to the proximal portion. The pressure difference between the pressure in the 458 and the pressure in the first reservoir 462 can be reduced. Holes 466 may allow gas (or liquid) to flow from the first reservoir 462 into the aisle and into the container (not shown). Some embodiments include a plurality of holes 466, which can facilitate fluid inflow and / or outflow from the first reservoir 462. Many different plungers are disclosed herein. Any plunger can be used with any syringe system disclosed herein.

The proximal plunger seal 460 may have a contact area 480, where the contact area 480 is the area of the proximal plunger seal 460 that can contact the inner diameter of the plunger 450, or the proximal plunger seal 460 is distal or near along it. Another inner surface of the plunger 450 that forms a sealing surface that slides in the proximal direction. In some embodiments, the length of the contact area 480 is at least about 25% of the inner diameter of the plunger, at least about 50% of the inner diameter of the plunger, at least about 25% of the inner diameter of the plunger and / or about 200 of the inner diameter of the plunger. % Or less, at least about 40% of the inner diameter of the plunger and / or about 75% or less of the inner diameter of the plunger, or at least about 50% of the inner diameter of the plunger and / or about 100% or less of the inner diameter of the plunger. In some embodiments, the length of the contact area 480 is at least about 0.2 centimeters and / or about 3 centimeters or less, at least about 0.5 centimeters and / or about 2 centimeters or less, or at least. It is about 0.7 cm and / or less than about 1.5 cm.

In some embodiments, the proximal plunger seal 460 is lubricated to facilitate sliding within the plunger 450. In certain embodiments, the inner diameter of the plunger 450 may be lubricated. Petroleum-based lubricants and silicone lubricants are used in some embodiments. Some embodiments do not use lubricants.

One embodiment of the plunger 450 is configured to stop the proximal plunger seal 460 from moving proximally beyond a certain position (eg, the most recent position). In some embodiments, the proximal plunger seal 460 has a starting or shipping position that is not in the nearest position. The distance between the most recent position that the proximal plunger seal 460 can reach and the location of the proximal plunger seal 460 is called the gap distance 484. In some embodiments, the clearance distance may facilitate post-manufacturing pressure changes (eg, increase). For example, if a pressure regulating syringe system is manufactured at sea level and then used at an altitude of 2,000 meters, the proximal plunger seal 460 must be properly moved proximally to the first reservoir. The pressure at 2,000 meters is considered to be higher than the ambient pressure. A sufficiently large gap distance of 484 reduces the ambient pressure by increasing the volume of the first reservoir 462 and reducing the pressure difference between the inside of the first reservoir 462 and the outside of the first reservoir 462. Can be dealt with. In some embodiments, the clearance distance 484 is at least about 0.5 centimeters and / or about 10 centimeters or less, at least about 1 centimeter and / or about 5 centimeters or less, or at least about 1.5 centimeters. Less than a meter and / or about 4 centimeters. Some methods include shipping the plunger 450 to a customer when the clearance distance has one of the dimensions or dimensional ranges described above.

As shown in FIG. 12, some embodiments of the plunger 450 include a fixing or locking portion 488. This can be used to hold the proximal plunger seal 460 in one place until a sufficiently large pressure difference overcomes the lock 488. The locking portion 488 may be a protrusion and / or a protrusion (eg, a rounded ridge) that projects radially inward from the inner diameter of the plunger 450.

In some embodiments, the first reservoir 462 is pressurized so that the initial pressure or the pressure at the time of shipment to the customer is not the ambient pressure. In some embodiments, the proximal plunger seal 460 can move to the most recent position and to the most distal position. The first reservoir 462 can be pressurized until the proximal plunger seal 460 reaches the most recent position (eg, the most recent position) and is subsequently applied so that the pressure in the first reservoir 462 is greater than the ambient pressure. Can be overwhelmed.

FIG. 13 illustrates a cross-sectional view of an embodiment of a pressure regulating syringe system 500 connected to a container 304 such as a vial. The system 500 may be the same as or identical to any of the other pressure regulating syringe systems described herein and may include any of the features of such other systems. The syringe system 500 may include a bag 504 that houses a first reservoir 508. The embodiment illustrated in FIG. 13 does not include a needle. In this embodiment, instead of using a needle to penetrate the septum 370, a penetration member 512 is used to penetrate the septum 370. In some variants, the penetration member 512 can be made from molded plastic with a hardness of 50 shore D to 85 shore D. Some embodiments include needles.

Septam 370 can be an elastomeric material that, when pierced by an article, can be transformed to form a substantially airtight seal around the article. For example, in some examples, Septam 370 comprises silicone rubber or butyl rubber.

A portion of the first passage 320 configured to pass through the septum 370 may be disposed within the penetration member 512. A portion of a second passage 324 configured to pass through the septum 370 may be placed within the penetration member 512. In some embodiments, the penetration member 512 can be a tapered or rounded lance that includes a portion of the first passage 320 and a portion of the second passage 324. The distal end 516 of the first passage 320 can exit the penetrating member 512 at the distal end of the penetrating member 512 or within about 1 cm from the distal end of the penetrating member 512. The distal end 520 of the second passage 324 can exit the penetration member 512 at the distal end of the penetration member 512 or within about 1 cm from the distal end of the penetration member 512.

The bag 504 can be made of a compliant material that can increase or decrease the internal volume of the bag 504. As mentioned above, the internal volume of the bag can be the first reservoir 508. In some embodiments, the inside of the bag 504 (eg, the first reservoir 508) can communicate fluidly with the inside of the container 304. For example, in one variant, the gas and / or liquid placed in the first reservoir 508 travels through the hole 410, through the area 398, through the first passage 320, and then (is a vial). (Get) can enter container 304.

The vent 420 allows the ambient air 244 to equalize or at least reduce the difference between the pressure in the first reservoir 508 and the ambient pressure. Ambient air 244 can enter through the vent 420 and come into contact with the outer surface of the bag 504 (eg, the surface of the bag 504, at least partially opposite to the first reservoir 508). In some embodiments, ambient air 244 cannot enter bag 504. An expansion reservoir, such as the bag 504, may be configured to open, expand, expand, contract, bulge, deflate, compress, and / or restore (decompressed). The bag 504 can change from a collapsed configuration having a first internal volume of the first reservoir 508 to an expanded configuration having a second internal volume of the first reservoir 508, where a second. The internal volume is larger than the first internal volume.

As shown in FIG. 13, in some embodiments, the bag 504 is housed in a plunger 394. In some embodiments, the bag 504 is located within the plunger 394. In some embodiments, the bag 504 is located inside a portion of the syringe assembly 302. In some embodiments, at least about 50 percent and / or about 90 percent or less of the bag is contained within the plunger 394, and at least about 40 percent and / or about 95 percent or less of the bag is contained within the plunger 394, or , At least about 75 percent and / or about 99 percent or less of the bag is contained within the plunger 394. The plunger 394 may accommodate at least a portion of the bag 504. In some variants, the plunger 394 is a rigid and / or plastic housing. The housing may be configured to enclose and / or protect the bag 504.

In some embodiments, the bag 504 is configured to stretch (such as a balloon made of rubber or latex). In some embodiments, the bag 504 is not configured to stretch and / or hardly stretches. In various embodiments, the bag 504 can change from a collapsed configuration that basically has no internal volume to an extended configuration that has an internal volume.

FIG. 14 illustrates a cross-sectional view of an embodiment of a pressure regulating syringe system 600 connected to a container 304 such as a vial. The system 600 may be the same as or identical to any of the other pressure regulating syringe systems described herein and may include any of the features of such other systems. The syringe system 600 may include a second passage 604 that allows the second reservoir 312 to communicate fluidly with the inner portion of the container 304. The second passage 604 may pass through the penetration member 608.

The syringe system 600 may include a pressure equalizer that may include a first passage 612 configured to allow the inner portion of the container 304 to communicate with a gas such as ambient air 244 located outside the syringe system 600. .. Since the first passage 612 allows the vent 616 to communicate with the inner portion of the container 304, the vent 616 allows gas outside the syringe system 600 to pass through the vent 616, then through the first passage 612, and then through the first passage 612. It is configured to allow entry into the inner portion of the container 304. The syringe system 600 may be configured to allow the gas inside the container 304 to pass through the first passage 612 and then out the syringe system 600 through the vent 616. Since the pressure equalizer may include a filter 620, the gas that passes through the vent and enters the vessel 304 will also pass through the filter 620. Since the pressure equalizer may include a filter 620, the gas exiting the container 304 through the vent 616 will pass through the filter 620. At least a portion of the first passage 612 may be located within the penetration member 608. In some embodiments, the vent 616 exits the syringe system 600 at the coupling system 350, barrel 390, plunger 394, or finger grips 414, 402.

FIG. 15 illustrates a cross-sectional view of an embodiment of a pressure regulating syringe system 700 connected to a container 304 such as a vial. The system 300 may be the same as or identical to any of the other pressure regulating syringe systems described herein and may include any of the features of such other systems. The syringe system 700 includes a valve 704 with open and closed positions. In the open position, valve 704 allows gas outside the syringe system 700 (such as ambient air 244) to enter the first passage 320. The valve 704 may include a cap 708 that covers the inlet of the first passage 320. In some embodiments, the user can open the cap 708 by pulling one side of the cap 708 away from the barrel 390 with a finger. The valve 704 may include a filter.

The barrel 390 may include a coupling system 350 at the distal end of the barrel 390. In some embodiments, the barrel 390 is detachably or non-detachably coupled to the coupling system 350 at the distal end of the barrel 390. The barrel 390 may include a proximal seal 716 at the proximal end of the barrel 390. The proximal seal 716 may have a hole in which the shaft of the plunger 720 is slidably arranged.

As shown in FIG. 15, the first reservoir 712 may be located inside a portion of the barrel 390 between the distal plunger seal 316 and the proximal seal 716. The proximal seal 716 is configured to allow a portion of the plunger 720 to slide in or out of a portion of the barrel 390 without leaking gas located within the first reservoir 712 from the first reservoir 712. obtain. In some embodiments, the proximal seal 716 may be configured to allow the plunger 720 to slide in and out of a portion of the barrel 390 while blocking or reducing gas leakage from within the first reservoir 712. The distal end of the plunger 720 may be connected to a split member such as the distal plunger seal 316, which is configured to separate and / or seal the second reservoir 312 from the first reservoir 712. Can be done.

In some embodiments, the first reservoir 312 and the inside of the container 304 communicate with fluid. For example, the gas disposed in the first reservoir 712 can flow into the first passage 320 and then into a portion of the container 304. The gas disposed within a portion of the container 304 can flow into the first passage 320 and then into the first reservoir 712. In some embodiments, the gas flow is blocked, obstructed, and / or prevented by valves and / or seals. Gas flow can be temporarily blocked or prevented, for example, until a proper connection is created between the pressure regulating syringe system and a container such as a vial. In some embodiments, proper connection occurs when the arm 354 engages the neck 358 and / or when the penetration member 512 penetrates the septum 370.

The second reservoir 312 may be configured to remove a substance (eg, a liquid drug) from the container 304. The second reservoir 312 may be configured to add a substance (eg, saline, liquid solvent, water) to container 304. Extraction and / or addition of material can be done via a second passage 324, where the second passage 324 may include a valve 232 (shown in FIG. 7). In some embodiments, the first reservoir 712 and the second reservoir 312 are approximately coaxial, with the first reservoir 712 located relatively proximal to the second reservoir 312. Many other reservoir configurations are also possible. In some embodiments, the first and second reservoirs are not coaxial. In some embodiments, the first reservoir and the second reservoir are two generally similar figures (eg, two generally cylindrical objects). The reservoirs can be placed side by side (rather than end-to-end). Some embodiments include three, four, and / or five reservoirs.

16 and 17 illustrate side views of embodiments of the pressure regulating syringe system 800. FIG. 16 illustrates the system 800 itself, and FIG. 17 illustrates the system 800 connected to a container 304 such as a vial. The system 800 may be the same as or identical to any of the other pressure regulating syringe systems described herein and may include any of the features of such other systems.

The system 800 may include a first reservoir 804 located next to (eg, radially outside) the second reservoir 808. In some embodiments, the first reservoir 804 is configured to contain a gas such as air, the second reservoir 808 is a liquid used in treatments, medical procedures, and / or formulations, etc. It is configured to contain the liquid of. The syringe system 800 may include a third reservoir 812 that is located beside at least a portion of the first reservoir 804 and / or that is located approximately coaxially with respect to the second reservoir 808. In some embodiments, the third reservoir 812 is in fluid communication with the inner portion 810 of the first reservoir 804 and / or container 304.

The first passage 816 can fluidly connect the first reservoir 804 to the inner portion of the container 304. The first passage 816 can pass through at least a part of the first penetration member 820. The second passage 826 can fluidly connect the second reservoir 808 to the inner portion of the container 304. The second passage 826 can penetrate at least a portion of the second penetration member 830, and the second penetration member 830 can be a protrusion with a tapered or rounded tip, such as a plastic lance. Some embodiments include penetrating members that are metal needles.

The first reservoir 804 is larger than the maximum volume of the second reservoir 808, at least 50% larger, at least 25% larger, smaller than the maximum volume of the second reservoir 808, at least 25% smaller, at least 50% smaller. , Or may have a maximum volume equal to the maximum volume of the second reservoir 808.

In some embodiments, the first reservoir 804, the second reservoir 808, and / or the third reservoir 812 is the pressure between the ambient air and the pressure of the inner portion 810 of the reservoir and / or container 304. It has a pressure regulator 240 that can reduce the difference. In some embodiments, the pressure regulator 240 is a bag, variable volume, valve, and / or seal that is configured to vary in size of the internal volume.

FIG. 18 illustrates a side view of an embodiment of a pressure regulating syringe system 850 that includes a bag 854 arranged within a housing 858 that may be rigid. The system 850 may be the same as or identical to any of the other pressure regulating syringe systems described herein and may include any of the features of such other systems. Since the rigid housing 858 can be arranged within the footprint of the coupling system 350, the rigid housing 858 does not extend radially outward from the maximum width portion of the coupling system 350. Bag 854 may include a first reservoir 862. The first reservoir 862 may be configured to communicate fluidly with the first passage 816. The housing 858 may include a vent 870 to allow ambient air 244 to contact the outer surface of the bag 854.

FIG. 19 illustrates a perspective view of an embodiment of the pressure adjusting syringe system 900. The pressure regulating syringe system 900 may be the same as or identical to any of the other pressure regulating syringe systems described herein and may include any of the features of such other systems. In some embodiments, the system 900 has a first reservoir 904 that is coaxial with at least a portion of the second reservoir 908. In one variant, at least a portion of the first reservoir 904 and / or at least 50% of the volume of the first reservoir 904 is located radially outward from the second reservoir 908. The second reservoir 908 may be located, at least in part, within the first reservoir 904. For example, the second reservoir 908 may be partially or completely located within the first reservoir 904, which may be generally cylindrical and may also be generally cylindrical.

The syringe system 900 may include a penetration member 912 and a plunger 916. The syringe system 900 may be connected to the vessel 304 such that the penetration member 912 is at least partially located within the vessel 304 (shown in FIG. 17). At least a portion of the penetration member 912 can communicate fluidly with the first reservoir 904 and the second reservoir 908.

The syringe system 900 moves the plunger 916 distally so that fluid exits the second reservoir 908, exits the penetration member 912, and is drawn through the penetration member 912 into the first reservoir 904. Can be configured in. The syringe system 900 moves the plunger 916 proximally so that fluid exits the first reservoir 904, exits the penetration member 912, and is drawn into the second reservoir 908 through the penetration member 912. Can be configured in. Syringe systems (such as any of the syringe systems described herein) allow fluid to enter the first reservoir, drain the fluid from the second reservoir, and / or into the second reservoir. When fluid is added, it may be configured to exit the first reservoir.

FIG. 20 illustrates a method of using a syringe system (such as any of the syringe systems disclosed herein). Block 1000 may include sealing the first reservoir when the syringe system is not mechanically connected (eg, connected) to a container such as a vial. In some embodiments, the first reservoir is configured to contain a gas that helps reduce the pressure difference between the inside and outside of the container. Sealing the first reservoir may include obstructing the flow of gas into or out of the first reservoir. Since some sealing embodiments are not perfect, some sealing embodiments are radically sealed and / or into or from a first reservoir. Including minute leaks or diffusion. Sealing the reservoir may include reducing any gap into or from the reservoir to less than 0.002 inches. Block 1004 may include sealing a second reservoir when the syringe system is not mechanically connected (eg, connected) to the container. In some embodiments, the second reservoir is configured to contain a liquid, such as a liquid used in a therapeutic or medical procedure.

Block 1008 may include sealing the first reservoir from the second reservoir when the syringe system is not mechanically connected (eg, connected) to the container. In some embodiments, the first passage (in fluid communication with the first reservoir) and the second passage (in fluid communication with the second reservoir) end in a closed area. Thus, when the plunger is moved (eg pushed), the fluid can flow through the closed area from the first reservoir to the second reservoir or from the second reservoir to the first reservoir. In these embodiments, the first reservoir is not sealed from the second reservoir because fluid can flow between these reservoirs. Sealing the first reservoir from the second reservoir helps prevent fluid from flowing between these reservoirs.

Block 1012 may include fluid communication of the first reservoir with the inner portion of the container when the syringe system is mechanically connected (eg, connected) to the container. The inner portion can be the internal volume of the container, such as an internal volume configured to contain a liquid or gas. Fluid communication of the reservoir with the vessel can include fluid connection of the reservoir with the vessel through passages such as lumens or channels. Block 1016 may include fluid communication of a second reservoir with the inner portion of the container when the syringe system is mechanically connected (eg, connected) to the container.

The various methods described herein can be performed in a different order than that shown in the exemplary embodiments. Many of the embodiments of the methods described herein may include optional blocks, steps, parts, and elements. For example, some embodiments of the method of FIG. 20 include block 1000 but not block 1004. None of the elements of the various methods described herein are essential or definitive.

FIG. 21 illustrates a method of using a syringe system (such as any of the syringe systems disclosed herein). Block 1020 may include sealing the first passage when the syringe system is not mechanically connected (eg, connected) to a container such as a vial. Block 1024 may include sealing the second passage when the syringe system is not mechanically connected (eg, connected) to the container. The first passage may be fluid connected to a first reservoir that may be configured to contain the gas. The second passage may be fluid connected to a second reservoir that may be configured to contain the liquid. Block 1028 may include fluid communication of the first passage with the inner portion of the container while sealing the first passage from the ambient environment and sealing the first passage from the second passage. The ambient environment is the external environment of the syringe system, outside the container (eg, ambient air 244 in FIG. 7). In some embodiments, the first passage is sealed from the ambient environment when the first passage is in fluid communication with the inner portion of the container, and / or the first passage is the inner portion of the container. Includes sealing the first passage from the second passage when communicating with the fluid.

Block 1032 may include fluid communication of the second passage with the inner portion of the container while sealing the second passage from the ambient environment and sealing the second passage from the first passage. In some embodiments, the second passage is sealed from the ambient environment when the second passage is in fluid communication with the inner portion of the container, and / or the second passage is the inner portion of the container. Includes sealing the second passage from the first passage when communicating with the fluid.

FIG. 22 illustrates a method of using a syringe system, such as any of the syringe systems disclosed herein. Block 1040 may include compressing a first urging member (such as a first spring) to open a first passage when connecting the syringe system to a container such as a vial. The first passage may be configured to fluidly connect the first reservoir to the inner portion of the vessel. Block 1044 may include compressing a second urging member (such as a second spring) to seal the second passage from the ambient environment. Block 1048 may include compressing a third urging member (such as a third spring) to seal the second passage from the first passage. The second passage may be configured to fluidly connect the second reservoir to the inner portion of the vessel. The ambient environment is the external environment of the syringe system, outside the container (eg, ambient air 244 in FIG. 7). In some embodiments, the first urging member, the second urging member, and / or the third urging member is actually one urging member (eg, one spring). In some embodiments, the second urging member and the third urging member are actually one urging member (eg, spring 1504 in FIG. 41), and the first urging member is another. An urging member (eg, spring 1558 in FIG. 41).

Block 1052 may include moving a liquid or gas through the first passage. Block 1056 may include moving a liquid or gas through a second passage. Moving the liquid and / or gas may include moving the liquid and / or gas into and / or out of the syringe system. Moving the liquid and / or gas may include moving the liquid and / or gas into and / or out of a container such as container 304 in FIG.

The spring can be any mechanical device, such as an elastic device that stores energy, such as axial energy. The spring can be made from spring steel. The energy stored by the spring may be proportional to the change in spring length. Some embodiments include coil springs, coil springs, tension springs, compression springs, torsion springs, constant springs, variable springs, thin leaf springs, machines. Processed springs, cantilever springs, leaf springs, V-shaped springs, countersunk springs, gas springs, springs, spring washers, and corrugated springs are used. In some embodiments, the spring is replaced by an axially responsive member, such as a silicone cylinder having lumens in the axial direction of the cylinder.

FIG. 23 illustrates a method of using a syringe system, such as any of the syringe systems disclosed herein. The user or machine can flow the fluid by pushing the plunger, pulling the plunger, and / or creating a pressure difference that drives the fluid flow. The fluid can be a gas or a liquid. Block 1060 may include flowing fluid in the first reservoir in the first distal direction. For example, in FIG. 8, the fluid can flow from the central portion of the first reservoir 308 towards the hole 410. Block 1064 may include flowing fluid radially outward from the first reservoir to the area forming the channel. For example, in FIG. 8, fluid can flow radially outward from the first reservoir 308 through hole 410 to area 398. Area 398 forms a channel through which fluid can flow. Block 1068 may include flowing fluid proximally within the channel. For example, in FIG. 8, the fluid is within area 398 from the distal part of area 398 (eg, the distal part near hole 410) to the proximal part of area 398 (eg, near the entrance 322 of the first passage 320). Can flow towards (proximal part of).

Block 1072 may include flowing fluid radially outward from the channel to the first passage. For example, in FIG. 8, the fluid can flow radially outward from the proximal portion of the area 398 and enter the proximal portion of the first passage 320 through the inlet 322. Some embodiments include flowing the fluid out of the first reservoir and into the first passage. Block 1076 may include flowing fluid in a second distal direction within the first passage. For example, in FIG. 8, the fluid can flow from the proximal portion of the first passage 320 to the distal portion of the first passage 320 (eg, towards the container 304). Block 1080 may include the influx of fluid into an inner portion of a container such as a vial.

In some embodiments, in each direction of block 1060, block 1064, block 1068, block 1072, block 1076, and block 1080, the fluid flows from the container (eg, container 304 in FIG. 8) to the first reservoir (eg, FIG. 8). It is in the opposite direction so that it flows in 308). Various embodiments of the method of FIG. 23 may include mechanically and / or fluidly connecting the syringe system to a container such as a vial. Some embodiments use containers that are not vials.

FIG. 24 illustrates a method of using a syringe system, such as any of the syringe systems disclosed herein. Block 1090 may include removing the drug from a first container such as a vial. Some embodiments include the use of a vial adapter while removing the drug from the first container. Block 1094 may include disconnecting a first adapter, such as a vial adapter, from the syringe. Block 1098 may include connecting a second adapter to a second container. The second container can be an intravenous therapy (“IV”) bag or an IV line. The second adapter may be configured to mechanically and / or fluidly connect the syringe to the second container. Block 1102 may include connecting the syringe to a second adapter. Block 1106 may include injecting the drug into a second container. Block 1110 may include opening a pressure regulating valve and / or a valve such as a valve that allows ambient air or ambient air that has passed through a filter to enter the syringe.

FIG. 25 illustrates a side view of an embodiment of a pressure regulating syringe system 1200 that emphasizes further details of the coupling system. The system 1200 may be the same as or identical to any of the other pressure regulating syringe systems described herein and may include any of the features of such other systems. The syringe system 1200 may include a syringe assembly 1204 and an adapter assembly 1208. Adapter assembly 1208 may be configured to connect syringe assembly 1204 to a container such as a vial, IV bag, or IV line. A threaded portion 1212 near the distal portion of the syringe assembly 1204 may be connected to the threaded portion 1216 of the adapter assembly 1208. Some embodiments include screwing the syringe assembly 1204 to the adapter assembly 1208. Various embodiments, such as the embodiments illustrated in FIG. 25, can be connected to the adapter assembly 1208 in any direction of rotation along the central axis of the syringe assembly 1204. Therefore, the syringe assembly 1204 and the adapter assembly 1208 of FIG. 25 and various other embodiments do not require a particular direction of rotation. Not requiring a specific direction of rotation can facilitate easier connection and reduce connection errors. The lack of the required direction of rotation can be called "rotational independence". Many embodiments described herein, such as those illustrated in FIGS. 25, 40, 48, and / or 62, have rotational independence.

Syringe assembly 1204 may include barrel 1220. The first reservoir 308 and the second reservoir 312 may be located inside the barrel 1220. The proximal first passage 1224 may be located inside the barrel 1220. The proximal first passage 1224 may be located outside the first reservoir 308 and / or outside the second reservoir 312. The central axis 1230 of the syringe assembly 1204 is illustrated by the dashed line. The proximal first passage 1224 may be located radially outward from the central axis 1230, the first reservoir 308, the second reservoir 312, and the plunger 394, as indicated by the dashed arrow. The proximal first passage 1224 includes a proximal opening 1234 and a distal opening 1238. Proximal opening 1234 can communicate with the area 398 forming the channel. Area 398 may communicate fluid through the first reservoir 308 and hole 410. The distal opening 1238 is configured to allow fluid communication with the proximal opening 1242 of the first passage 1246 distal to the adapter assembly 1208 when the syringe assembly 1204 is connected to the adapter assembly 1208. ..

The syringe assembly 1204 is configured so that when the syringe assembly 1204 is connected to the adapter assembly 1208, it is in fluid communication with a second passage 1254 distal to the adapter assembly 1208. Can have 1250.

As illustrated in FIG. 25, the syringe assembly 1204 and / or the adapter assembly 1208 may include seals 1260, 1264. Seals 1260, 1264 are between any combination of the first reservoir 308, the second reservoir 312, and / or the inner portion of the container when the syringe assembly 1204 is mechanically connected to the container. It may be configured to promote a substantially airtight seal, an airtight seal, and / or a liquidtight seal. For example, seals 1260, 1264 may seal the first passages 1224, 1246 from the ambient environment (eg, ambient air 244) and / or seal the first passages 1224, 1246 from the second passages 1250, 1254. Can stop.

In some embodiments, the seals 1260, 1264 can be any type of sealant or gasket, such as an O-ring. Some seal embodiments may be made from medical grade silicone or neoprene. The O-ring can be placed in a groove that is at least 10% wider than the thickness of the O-ring. The width of the groove can be measured in a direction parallel to the central axis of the syringe assembly 1204. The groove depth can be measured in a direction perpendicular to the central axis of the syringe assembly 1204. The thickness of the O-ring may be equal to 50% of the outer diameter of the O-ring minus the inner diameter. The thickness can also be determined by laying the O-ring on a flat surface and then measuring how far the O-ring extends perpendicular to this flat surface. In some embodiments, the seals 1260, 1264 are radial sealing members that seal a portion of the adapter assembly 1208 to a portion of the syringe assembly 1204. The radial sealing member, such as the seals 1260, 1264, illustrated in FIG. 25, is a support 1268 (eg, plastic and / or rigid cylindrical support) of an adapter or syringe (eg, adapter assembly 1208, syringe assembly 1204). Can be placed around. In some embodiments, the inner diameter of the radial sealing member seals against the support 1268 and the outer diameter of the radial sealing member seals against the inner surface 1272 (eg, inner diameter) of the syringe or adapter. To do.

FIG. 25 illustrates a pressure regulating syringe system 1200 when the syringe assembly 1204 is not connected to the adapter assembly 1208. FIG. 26 illustrates a pressure regulating syringe system 1200 when the syringe assembly 1204 is connected to the adapter assembly 1208. For example, the syringe assembly 1204 and the adapter assembly 1208 may be connected by corresponding threaded portions 1212, 1216. The proximal seal 1260 can prevent or prevent fluid from passing between the second passages 1250, 1254 and the first passages 1124, 1246 and / or leaking out of the syringe system 1200. The distal seal 1264 can prevent fluid from exiting the first passages 1224, 1246 and then entering the second passages 1250, 1254 and / or leaking out of the syringe system 1200. The adapter assembly 1208 may include a penetration member 1270.

FIG. 27 illustrates a side view of an embodiment of the pressure regulating syringe system 1290, where the seals 1274, 1278 are not placed in grooves (eg, diameter) on the outer surface, but on the inner surface. It is located in a groove (eg diameter) along it. The syringe system 1290 may include one or more proximal seals 1274 and / or distal seals 1278, which seals are the same as described for proximal seals 1260 and distal seals 1264 of FIGS. 25 and 26. Can perform its function. The system 1290 may be the same as or identical to any of the other pressure regulating syringe systems described herein and may include any of the features of such other systems.

FIG. 28 illustrates a side view of an embodiment of a pressure regulating syringe system 1300 that includes encapsulating gel 1304 and / or elastic encapsulant. System 1300 may be the same as or identical to any of the other pressure regulating syringe systems described herein and may include any of the features of such other systems. The sealing gel may be placed along the connecting interface between at least a portion of the syringe assembly 1204 and the adapter assembly 1208. In some embodiments, gel 1304 is a silicone gel suitable for medical use.

29 and 29A illustrate perspective views of embodiments of the syringe assembly 1402. Syringe assembly 1402 may include a plunger 1404 (eg, tube, actuator, shaft, etc.) and a barrel 1408 (eg, housing, casing, closed container, etc.). As described in detail below, the syringe assembly 1402 may be connected to the drug solution container by an adapter assembly 1450 (see FIG. 32) or the like to facilitate fluid transfer under pressure control.

29B and 29C illustrate side views and exploded views of the plunger 1404. The plunger 1404 may include any of the features of the plunger 450 described above. As shown, the plunger 1404 may include a distal plunger seal 1428 connected to the distal end of the plunger body 2800 by a seal coupler 2804. Proximal plunger seal 1412 can be inserted into the internal channel 1452 (shown in FIG. 29M) of the plunger body 2800. The proximal plunger seal 1412 may be pushed distally within the internal channel 1452 to form a first reservoir, such as a reservoir of regulated gas. A proximal end 2808 (eg, grip, handle, or end cap) may connect to the proximal portion of the plunger body 2800. This may facilitate holding the proximal plunger seal 1412 within the plunger body 2800.

29D-29G illustrate various diagrams of the proximal plunger seal 1412. 29H-29K illustrate various diagrams of the distal plunger seal 1428. 29L and 29M illustrate a perspective view of the plunger body 2800. As illustrated, the plunger body 2800 can be a hollow elongated member with one end partially closed. As shown, the plunger body 2800 may include one or more holes 466. 29N and 29O illustrate perspective views of the handle.

FIG. 29P illustrates a side view of the barrel 1408. Plunger 1404 (shown in FIG. 29B) can be inserted (eg, received) into the inner portion of barrel 1408. Typically, the plunger 1404 may slide within a portion of barrel 1408. For example, in some embodiments, the plunger 1404 can slide distally and proximally relative to barrel 1408.

FIG. 29Q illustrates an exploded perspective view of the barrel 1408. The barrel 1408 may include a barrel body 2816, which may be a hollow elongated member with one end partially closed. As shown, the barrel 1408 may include a proximal seal 1432, such as an O-ring, which may be held in place by the seal retainer 2820. A distal cap 1550 may connect to the distal end portion of the barrel body 2816. As shown, the barrel body 2816 may include one or more openings 1238.

FIG. 29R illustrates an exploded side view of a portion of barrel 1408. Barrel 1408 may include multiple seals. For example, the barrel 1408 may be a seal 1562 (referred to elsewhere herein as a third seal), a seal 1570 (referred to elsewhere herein as a fourth seal), and / or a seal 1588 (referred to elsewhere herein). Included elsewhere in the specification (referred to as the fifth seal). As shown, the seal 1562 is located within the groove 2828 of the movable member 2812 and / or is secured by the groove 2828. In some embodiments, the seal 1588 is located within the groove 2824 of the barrel body 2816 and / or is secured by the groove 2824.

Barrel 1408 may include a movable member 2812 that may be configured to slide distally and / or proximally. In some embodiments, the movable member 2812 slides relative to the central axis of the distal shaft 2832 of the barrel body 2816. The distal shaft 2832 can be urged by a urging member 1558, such as by a spring located around the distal shaft 2832. The spring 1558 may be configured to exert a distal force on the movable member 2812. In some embodiments, the seal 1570 is placed on the aisle shaft 1574 of the movable member 2812. In certain embodiments, some or all of the article shown in FIG. 29S is formed by molding. In one variant, the spring 1558 is a shaped metal.

FIG. 30 illustrates a cross-sectional view of the syringe assembly 1402 along line 30-30 of FIG. As illustrated, the proximal plunger seal 1412 can be slidably located inside the plunger 1404 so that the ambient air is located proximal relative to the proximal plunger seal 1412 through the vent 1436. It can flow into a part 1406 of the plunger 1404. Proximal seal 1432 can seal between an outer surface such as the outer diameter of the plunger 1404 and an inner surface such as the inner diameter of the barrel 1408. A fluid, such as a gas, can exit the first reservoir 1420 through the hole 466, travel within the proximal first passage 1416, and then exit the distal end of the syringe assembly 1402. A distal plunger seal 1428 may be connected to the distal end of the plunger 1404.

Next, with reference to FIGS. 29 and 31, a second reservoir 1444 may be located within the barrel 1408. For example, the second reservoir 1444 may be located between the distal plunger seal 1428 and the proximal second passage 1424. In some embodiments, at least a portion of the distal plunger seal 1428 is the movable proximal end of the second reservoir 1444, thus increasing the volume of the second reservoir 1444 (eg, in proportion to the movement of the plunger seal 1428). ) Can be changed. The second reservoir 1444 can communicate with at least a portion of the proximal second passage 1424.

The syringe assembly 1402 may include a peripheral portion 1406 that is located inside a portion of the syringe assembly 1402 and may be a third reservoir. A vent 1436 or hole may fluidly connect the peripheral portion 1406 to ambient air 244 located outside the syringe assembly 1402. In some embodiments, a third reservoir (eg, peripheral portion 1406) may be located inside a portion of the plunger 1404. The proximal plunger seal 1412 can fluidly separate the third reservoir from the first reservoir 1420. The third reservoir may be located within the proximal portion of the plunger 1404 and the first reservoir 1420 may be located within the distal portion of the plunger 1404. In some embodiments, the perimeter 1406 includes a reservoir that cannot form negative pressure internally (eg, relative to the perimeter) because the perimeter 1406 is fluid connected to the ambient air. ..

FIG. 31 illustrates a cross-sectional view of the syringe assembly 1402 of FIG. 30, where the plunger 1404 is located further proximal to the illustration of FIG. In the configuration of FIG. 31, the second reservoir 1444 has a larger (eg, at least 10 times larger) volume than when the plunger 1404 was pushed to its most distal position.

In some embodiments, the first and second reservoirs are located within one outer housing, so that as the volume of one reservoir decreases, the volume of the other reservoir increases. Referring to an embodiment illustrated in FIG. 31, the first reservoir 1420 and the second reservoir 1444 are in different housings (eg, barrel 1408 and plunger 1404), so that changes in the volume of one reservoir do not necessarily occur. The volume of the other reservoir does not change. Therefore, in some embodiments, the first reservoir 1420 and the second reservoir 1444 are "volumetrically independent". Volumetric independence is beneficial for changes in the volume of one reservoir (eg, when fluid is injected into or removed from the container), but the volume of the other reservoir does not need to change (eg,). , Because the container is compliant, there is no need to add or remove gas from the container), which may be convenient in some embodiments. Volume independence can make the syringe assembly more compatible with both rigid containers (eg glass vials) and responsive containers (eg IV bags). Without volume independence, situations can arise in which the pressure in the first reservoir and / or the pressure in the second reservoir is not approximately the same as atmospheric pressure (eg, the pressure of ambient air 244).

FIG. 32 illustrates a perspective view of the adapter assembly 1450. The distal end 1454 of the adapter assembly 1450 is configured to connect to the container. The proximal end 1458 of the adapter assembly 1450 is configured to connect to the syringe assembly 1402 illustrated in FIG.

FIG. 33 illustrates an axially disassembled side view of the adapter assembly of FIG. A first seal 1470, such as an O-ring, may be placed in the groove 1474 of the skirt 1478. The skirt 1478 can be a plastic or metal member configured to connect to the neck 358 (shown in FIG. 13) of the container 304. Skirt 1478 may include engaging portions having expansion aids such as slots 1482. In some embodiments, the skirt 1478 includes a plastic cylindrical protrusion having a slot 1482 that expands (eg, increases in diameter) when it gets over the lip 362 and then connects to the neck 358. Shrinkage (eg, diameter reduction) can be reduced (see FIG. 13).

Skirt 1478 may include elastic latch members such as flexible arm 1480. The arm 1480 may be configured to bend outward and hang on the shoulder or protrusion 1422 of the syringe assembly 1402 (shown in FIG. 31). The flexible arm 1480 has a stem projecting proximally from the skirt 1478, a lever 1516 projecting distally from the stem 1512, a notch 1520 configured to flex the lever 1516, and / or radially inward. It may include a protruding protrusion 1524. In some embodiments, the syringe assembly 1402 (shown in FIG. 31) may include a latch member and the skirt 1478 may include a corresponding shoulder or protrusion 1422.

The adapter assembly 1450 may include a second seal 1486, such as an elastic boot. In some practices, the second seal 1486 can move approximately axially (eg, elastically collapse and / or expand). One embodiment of the second seal 1486 has an internal lumen 1490 configured to seal against the proximal shaft 1494 of the penetration member 1500. Proximal shaft 1494 may pass through the center of an urging member such as spring 1504. Some embodiments of the second seal 1486 are energized, biased and / or compressed by a spring 1504. The spring 1504 may be configured to push the second seal 1486 proximally. The distal end of the spring 1504 may be connected, pressed and / or placed on the penetration member 1500, and the proximal end of the spring 1504 may be connected, pressed and / or attached to a second seal 1486. Or it can be placed. In some embodiments, the distal end of the second seal 1486 is located inside a portion of the spring 1504 (eg, inside the internal space containing the central axis formed by certain helical features of the spring). , The proximal end of the spring 1504 is connected to and / or pressed against the radial protrusion 1508 of the second seal 1486. Although the spring 1504 is illustrated in the compressed state in FIG. 33, in many embodiments the spring 1504 can be in the uncompressed state unless compressed by an external force or external structure.

FIG. 34 illustrates a spring 1504 and a second seal 1486 located on the proximal shaft 1494. FIG. 34 also illustrates that the first seal 1470 can be placed in the groove 1474 (shown in FIG. 33) of the skirt 1478. The penetration member 1500 (which is connected to the spring 1504 and the second seal 1486) can be slid proximally in the direction indicated by the dashed arrow and connected to the skirt 1478.

FIG. 35 illustrates a top view of the adapter assembly 1450 of FIG. The adapter assembly 1450 may include at least one channel 1530 (eg, a slot), the channel 1530 having a first passage (eg 220 in FIG. 7, 320 in FIG. 8, 612 in FIG. 14, 816 in FIG. 16, 25. It may constitute a part of 1246). Channel 1530 allows a fluid, such as a gas, to bypass and / or flow around the sealing member of the adapter assembly 1450 and / or to flow out of the proximal portion of the adapter assembly 1450. Can be configured. One embodiment of channel 1530 allows the conditioning fluid to pass between the distal cap 1550 (shown in FIG. 37) of the syringe assembly 1402 and the proximal sealing portion 1502 (shown in FIG. 36A) of the adapter assembly. It is configured. Each channel 1530 may be located radially outward from the central axis of the adapter assembly 1450 and may be spaced apart from each other in the circumferential direction and / or along the inner diameter.

FIG. 36A illustrates a cross-sectional view taken along line 36-36 of FIG. 35. The adapter assembly 1450 may include a protrusion 1540 extending radially inward towards the central axis of the adapter assembly 1450. The inward projection 1540 projects into the neck area of the container (eg, 358 in FIG. 13) such that the lip (eg, 362 in FIG. 13) connects between the inward projection 1540 and the internal region of the adapter assembly 1450. Can be configured to.

FIG. 36A illustrates a second seal 1486 in a distal position for explanatory purposes. In some embodiments, when the second seal 1486 is in the distal position, one or more radial holes 1528 of the proximal shaft 1494 are in the open position (eg, unobstructed) and therefore far away. The second passage 1254 of the position can be opened. In various embodiments, the second seal 1486 can be in this position, for example, when the syringe assembly 1402 and the adapter assembly 1450 are connected (eg, as illustrated in FIG. 40). As shown in FIG. 36A, when the second seal 1486 is in the distal position, the distal first passage 1246 can be open (eg, in the open position).

As shown in FIG. 36B, in some embodiments, the spring 1504 applies a force in the proximal direction to push the second seal 1486 to the proximal sealing position 1502. When the second seal 1486 is in the proximal sealing position 1502, the radial protrusion 1508 seals against the medial tapered region 1518 so that the first seal is completely or at least partially distal. The passage 1246 can be sealed. In some embodiments, the radial protrusion 1508 may partially or wholly block fluid communication in the distal first passage 1246 (eg, by sealing against the medial tapered region 1518). it can.

In some embodiments, when the second seal 1486 is in the proximal sealing position 1502, the second seal 1486 partially and / or completely occludes one or more radial holes 1528 and is distal. The second passage 1254 can be sealed and / or closed. In some embodiments, when the syringe is not connected to the adapter assembly 1450, the spring 1504 moves the second seal 1486 to the proximal sealing position 1502 and the distal first passage 1246 and / Or block, seal, and / or obstruct the distal second passage 1254. In FIG. 36A, for explanatory purposes, the spring 1504 is shown in a compressed state to illustrate how the distal first passage 1246 and the distal second passage 1254 can be open. However, in many embodiments, the spring 1504 expands to position the second seal 1486 in the proximal seal position, unless components (eg, the axial sealing surface 1592 in FIG. 41) compress the spring 1504. It will be pushed to 1502.

The penetrating member may include at least a portion of the distal first passage 1246 and at least a portion of the distal second passage 1254. The skirt 1478 may include at least a portion of the distal first passage 1246 and at least a portion of the distal second passage 1254. The distal first passage 1246 and the distal second passage 1254 are indicated by dashed lines.

FIG. 36B illustrates a cross-sectional view in which the second seal 1486 is in a proximal position (eg, proximal sealing position 1502). An urging member (eg, spring 1504) can move (eg, push) the second seal 1486 to the proximal sealing position 1502, resulting in a radial protrusion 1508 of the second seal 1486 of the adapter assembly 1450. Contact (eg, sealing) with an inner portion (eg, medial taper portion 1518) to impede and / or block the flow of fluid within the distal second passage 1254 and / or the distal first passage 1246. Will be done. At the proximal sealing position 1502, the second seal 1486 can impede and / or block the flow of fluid through the radial hole 1528, which is the exit channel of the distal second passage 1254. obtain. At the proximal sealing position 1502, the second seal 1486 can impede and / or block the flow of fluid along the passage illustrated by the dashed line in FIG. 36A.

In FIG. 36B, the spring 1504 is illustrated in an extended configuration. Connecting the syringe assembly 1402 (shown in FIG. 29) to the adapter assembly 1450 allows the spring 1504 to be compressed to move the second seal 1486 to a distal unsealed position. The distal unsealed position as an example is illustrated in FIG. 36A.

FIG. 37 illustrates a perspective view of the distal portion of the syringe assembly 1402 illustrated in FIG. 29. The syringe assembly 1402 may include a distal cap 1550 configured to connect with a mounting zone 1554 near the distal end of barrel 1408. The distal cap 1550 may be connected to barrel 1408 by ultrasonic welding, gluing and / or snap fitting. FIG. 37 illustrates the syringe assembly 1402 before the distal cap 1550 is connected to the barrel 1408.

The syringe assembly 1402 may include an urging member such as a spring 1558. The spring 1558 may exert an axial force (eg, approximately towards the distal end of the syringe assembly 1402 and / or approximately towards the proximal end of the syringe assembly 1402). The spring 1558 pushes one or more third seals 1562 (which can be O-rings arranged in the groove) towards the tapered surface to create a first passage (eg, a first proximal passage in FIG. 31). The passage 1416) may be configured to close and / or seal. In some embodiments, the spring 1558 may push the support (eg, sliding member 1576) with the third seal 1562 towards a tapered surface. The tapered surface can be the inner surface 1580 of the distal cap 1550.

As detailed below, the sliding member 1576 can reciprocate proximally and distally. For example, the sliding member 1576 can slide up and down on the distal shaft 2832 of the barrel body 2816. As shown, the sliding member 1576 may include one or more axial protrusions 1566, such as a distally extending flexible or rigid arm. Axial projections 1566 can extend in a direction approximately parallel to the central axis of the syringe assembly 1402.

Syringe assembly 1402 may include a fourth seal 1570, the fourth seal 1570 may be a generally cylindrical seal having lumens and / or a seal having a cylindrical portion and a central lumen. The aisle shaft 1574 may accommodate a second aisle (eg, a second aisle 1424 proximal to FIG. 31). The aisle shaft 1574 may pass through the lumens of the fourth seal 1570, which may be made of rubber or any other suitable material. Any of the seals described herein can be made from rubber, such as medical grade rubber, or any other suitable encapsulant.

Syringe assembly 1402 may include a fifth seal, such as an O-ring, 1588 (see FIG. 38). The fifth seal 1588 may be held in a groove such as the distal shaft 2832. The fifth seal 1588 may provide a generally liquid and / or airtight seal between the sliding member 1576 and the distal shaft 2832.

38 and 39 illustrate a cross-sectional view of the distal portion of the syringe assembly 1402. The adapter assembly (eg, 1450 in FIG. 40) is not shown in FIGS. 38 and 39 for the sake of more clarity of the exemplary features and components. In FIG. 38, the syringe assembly 1402 is shown in a configuration that is not connected to an adapter assembly (eg, 1450 in FIG. 40). On the other hand, in FIG. 39, the syringe assembly 1402 is shown as connected to an adapter assembly (eg, 1450 in FIG. 40), but for illustration purposes, the adapter assembly is not shown in FIG. In FIG. 38, the syringe assembly 1402 can be said to be "closed" and in FIG. 39, the syringe assembly 1402 can be said to be "open".

As shown in FIG. 39, in the open position, the adapter assembly pushes the distal portion 1584 of the passage shaft 1574 in the proximal direction to open the proximal second passage 1424. Such movement can be contrary to the compressive force of the spring 1558. As illustrated, the sliding member 1576 and the distal portion 1584 of the passage shaft 1574 are configured by the proximal shaft 1494 (not shown) of the adapter assembly 1450 (not shown) (in the configuration shown in FIG. 38). It is pushed in the proximal direction (relative to). In some embodiments, as the sliding member 1576 moves proximally, the third seal 1562 separates from the inner surface 1580 (eg, tapered surface) and opens and / or opens, thereby the proximal first. At least the distal portion of passage 1416 can be opened. In some embodiments, the proximal movement opens and / or opens the proximal second passage 1424.

In some embodiments, the syringe assembly and / or adapter assembly comprises a residual volume of liquid after the syringe assembly has been disconnected from the container (eg, disconnected from the adapter assembly). The liquid may include formulations, drugs, and / or drugs. In some embodiments, the residual volume of the adapter assembly is less than about 0.2 milliliters, less than about 0.15 milliliters, less than about 0.11 milliliters, or less than about 0.05 milliliters. In some embodiments, the residual volume of the syringe assembly is less than about 0.18 ml, less than about 0.11 ml, less than about 0.07 ml, or less than about 0.01 ml.

In the embodiments illustrated in FIGS. 38 and 39, when the syringe assembly 1402 is disconnected from the adapter assembly 1450 (shown in FIG. 41), the second reservoir 1444 and / or the proximal second passage. Includes a mechanism to increase the effective volume of 1424. As the effective volume of the second reservoir 1444 and / or the proximal second passage 1424 increases, the local pressure can decrease so that the fluid (eg, during disconnection) is flushed to the second reservoir 1444 and / or proximal. Harmful that can be "sucked" or "sucked" into the second passage 1424 of the, and thus can drip and / or leak from the syringe assembly 1402 and / or the adapter assembly 1450 (shown in FIG. 41). The amount of liquid that can also be (eg, medical fluid, extracted drug fluid) can be reduced or minimized. This safety feature can make healthcare professionals less exposed to liquids.

In some embodiments, the sliding member 1576 is configured to move distally and proximally within the syringe assembly 1402, such as along the distal shaft 2832 of the barrel body 2816. When the syringe assembly 1402 is disengaged from the adapter assembly 1450 (shown in FIG. 41), the sliding member 1576 is moved distally by the force of the spring 1558. This distal movement expands the expansion chamber 1582, which expands into the proximal second passage 1424, in the second reservoir 1444, in any part of the syringe assembly 1402, and / Or may be located within any portion of the adapter assembly 1450 (shown in FIG. 41). In the embodiment illustrated in FIG. 38, the expansion chamber 1582 is located within the proximal second passage 1424. The expansion chamber 1582 is connected from the first volume when the syringe assembly 1402 is connected to the adapter assembly 1450 (shown in FIG. 41) and from the syringe assembly 1402 from the adapter assembly 1450 (shown in FIG. 41). It is configured to expand to a second larger volume when released. The increased volume of the expansion chamber 1582 facilitates "suction", "suction" or "pulling" of fluid into the syringe assembly 1402 from the syringe assembly 1402 and / or the adapter assembly 1450 (shown in FIG. 41). The occurrence of fluid leakage can be prevented and / or reduced.

FIG. 39 illustrates a first volume of expansion chamber 1582. In FIG. 39, the expansion chamber 1582 is too small to be seen and is highlighted by a dashed line. FIG. 38 illustrates a second volume of expansion chamber 1582. The expansion chamber 1582 is also highlighted in dashed line in FIG.

In some embodiments, the maximum volume of the expansion chamber 1582 is at least about 150% of the minimum volume of the expansion chamber 1582, or at least about 300% of the minimum volume of the expansion chamber 1582. In some embodiments, the maximum volume of the expansion chamber 1582 is at least about 200% of the minimum volume of the expansion chamber 1582 and / or about 10,000% or less of the minimum volume of the expansion chamber. In some embodiments, the maximum volume of the expansion chamber 1582 is at least about 400% of the minimum volume of the expansion chamber 1582 and / or about 2,000% or less of the minimum volume of the expansion chamber 1582.

In some embodiments, the expansion chamber 1582 has an internal volume of the syringe assembly 1402 (eg, volume of the second reservoir 1444, volume of the proximal second passage 1424) of at least about 0.2 ml and /. Or increase by about 25 milliliters or less, at least about 0.7 milliliters and / or about 10 milliliters or less, at least about 1 milliliter and / or about 3 milliliters or less, or at least about 2 milliliters and / or about 10 milliliters or less.

In FIG. 38, the third seal 1562 engages with the inner surface 1580 of the syringe assembly 1402 (eg, the inner surface of the distal cap 1550) to seal the proximal first passage 1416. In this configuration, fluid (such as gas) from the first reservoir (eg 1420 in FIG. 31) cannot pass through the first passage and exit the syringe. The third seal 1562, the inner surface 1580, and the spring 1558 can form a flow control unit such as a valve (eg, 228 in FIG. 7) to close and / or seal the first passage. .. By pressing the distal portion 1584 of the passage shaft 1574 in the axial direction, the axial spring force of the spring 1558 can be overcome. Overcoming the spring force allows the valve to open and allow fluids, liquids, and / or gases to flow.

FIG. 39 illustrates a valve in the open position. The third seal 1562 is no longer sealed to the inner surface 1580 because it is located away from the inner surface 1580. In some embodiments, the proximal end 1510 of the proximal shaft 1491 of the adapter assembly 1450 (shown in FIG. 33) engages (eg, contacts, pushes) the distal portion 1584 of the passage shaft 1574 of the syringe assembly 1402. Guess or other). This allows the spring 1558 to be moved (eg, compressed) so that the third seal 1562 does not seal against the inner surface 1580.

FIG. 40 illustrates a cross-sectional view of a pressure regulating syringe system comprising the syringe assembly 1402 of FIG. 29 and the adapter assembly 1450 of FIG. The system shown in FIG. 40 may be the same as or identical to any of the other pressure regulating syringe systems described herein and may include any of the features of such other systems.

FIG. 41 illustrates the distal portion of the system of FIG. 40. For clarity, all elements are not numbered. The spring 1504 may be configured to push the second seal 1486 proximally. The proximal end of the spring 1504 can be connected to and / or pressed against the radial protrusion 1508 of the second seal 1486. The spring 1504 may be configured to push the second seal 1486 towards the sealing surface of the syringe assembly 1402. The sealing surface can be an axially facing surface rather than a radial direction (although some embodiments include additional or alternative sealing surfaces facing the radial direction).

In FIG. 41, the second seal 1486 is connected between the spring 1504 and the axial sealing surface 1592. The second seal 1486 can provide a generally airtight seal and / or fluidly seal the proximal second passage 1424 and the distal second passage 1254 (shown in FIG. 28). Obtained, thereby facilitating the flow of fluid between the proximal second passage 1424 and the distal second passage 1254. Thus, fluid can flow between the second passages 1424, 1254, and the second passages 1424, 1254 can be fluidly isolated from the first passages 1416, 1246.

Barrel 1408 (a type of housing) may include an internal channel 1448 with a diameter. The second reservoir 1444 may be located within a portion of the internal channel 1448. Plunger 1404 may include an internal channel 1452. The first reservoir 1420 and the peripheral portion 1406 (which can be the third reservoir) can be located within the internal channel 1452 of the plunger 1404. The internal channel 1452 of the plunger 1404 may include a diameter. The proximal plunger seal 1412 may separate the internal channel 1452 into a first reservoir 1420 and a peripheral portion 1406. The first reservoir 1420 and the peripheral portion 1406 can be of equal diameter. The second reservoir 1444 may have a larger outer diameter than the first reservoir 1420 and the peripheral portion 1406.

In FIG. 41, a fluid path as an example is illustrated by a broken line. The first dashed line 1488 illustrates a first fluid path that fluidly connects the proximal first passage 1416 and the distal first passage 1246. The first dashed line 1488 passes behind the second seal 1486 in FIG. 41 (eg, around the circumferential rear portion of the second seal 1486). The second dashed line 1492 illustrates a second fluid path that fluidly connects the proximal second passage 1424 and the distal second passage 1254.

Various embodiments of the syringe assembly 1402 can be coupled to the adapter assembly 1450 at any angle around the longitudinal axis of the system 1400. For example, the syringe assembly 1402 is the longitudinal axis of the system 1400 without interfering with the ability of the system to deliver fluids (eg, gas, liquid) between the proximal first passage 1416 and the distal first passage 1246. Can be rotated relative to the adapter assembly 1450 (eg, at least about 90 degrees, about 135 degrees, about 180 degrees, about 210 degrees, about 650 degrees, or any other angle). In some embodiments, the syringe assembly 1402 does not interfere with the system's ability to deliver fluids (eg, gas, liquid) between the proximal second passage 1424 and the distal second passage 1254 (eg, gas, liquid). For example, it can be rotated at least about 45 degrees, about 110 degrees, about 290 degrees, about 500 degrees, about 1,000 degrees, values between the above values, or any other angle.

The fact that the syringe assembly 1402 can be rotated relative to the adapter assembly 1450 about its central axis can simplify connecting the syringe assembly 1402 to the adapter assembly 1450 and / or screw. The section may facilitate an embodiment in which the syringe assembly 1402 is connected (eg, tightened) to the adapter assembly 1450. In some screw-type embodiments, the syringe assembly 1402 cannot be rotated indefinitely relative to the adapter assembly 1450, but the syringe assembly 1402 is fully connected to the adapter assembly 1450 (eg,). , The threads can be rotated to fully or substantially completely engage). In some screw-type embodiments, the syringe assembly 1402 can be rotated infinitely relative to the adapter assembly 1450.

As shown in FIG. 41, the syringe assembly 1402 may include a penetrating member 1442. The penetration member 1442 may pass into at least a portion of the adapter assembly 1450. In some embodiments, the penetrating member 1442 does not penetrate as it passes into the adapter assembly 1450. In some embodiments, the penetrating member 1442 is blunt (eg, not sharp) during normal use so that it does not hurt a person even when it is exposed. In some embodiments, the penetrating member 1442 is numbered from the outer cover 1440 (FIG. 39) so that the penetrating member 1442 is inaccessible or at least nearly inaccessible to a person (during normal operation use). ) Is retracted inside. The outer cover 1440 can be part of the distal cap 1550, as shown in FIG.

In some embodiments, the distal end of the penetrating member is retracted from the distal end of the outer cover 1440 by at least 0.2 cm and / or about 11 cm or less. In some embodiments, the distal end of the penetrating member is recessed from the distal end of the outer cover 1440 by at least 0.5 cm and / or about 6 cm or less. In some embodiments, the distal end of the penetrating member is recessed from the distal end of the outer cover 1440 by at least 0.8 cm and / or about 3 cm or less.

In some embodiments, the components (eg, through member 1442) are configured to penetrate into a portion of the adapter assembly 1450 and / or into a portion of the container. The components (eg, through member 1442) are in the post-use state during the use of the system 1400 and / or when the syringe assembly 1402 is in the pre-use state (eg, when unpacked) (eg, when removed from the packaging). By retracting, covering, or otherwise by the syringe assembly 1402, when (for example, connected to and then disconnected from the adapter 1450), when initially placed, when disposed of and / or discarded. Can remain protected.

The proximal first passage 1416 can be a regulating channel for carrying or otherwise delivering a fluid that regulates the pressure in the vessel. The distal first passage 1246 can be a regulating channel for carrying or otherwise delivering a fluid that regulates the pressure in the vessel. The proximal second passage 1424 and the distal second passage 1254 may be withdrawal channels configured to remove the fluid from the container and / or deliver the fluid to the container.

As illustrated in FIG. 41, the syringe assembly 1402 may include a first urging member (eg, spring 1558) and / or an adjusting channel seal (eg, third seal 1562). The first spring 1558 may be configured to apply an axial force to press the adjustment channel seal against a sealing surface (eg, inner surface 1580), thereby sealing the adjustment channel.

The adapter assembly 1450 may include a penetrating member that projects distally (eg, the distal portion of the penetrating member 1500 in FIG. 36A). The penetrating member that projects distally may be configured to allow fluid communication with the inner portion of the container (eg, vial). The adapter assembly 1450 may include a member that projects proximally (eg, the proximal end 1510 of FIG. 36A), which compresses the first spring (eg, the spring 1558 of FIG. 41) and adjusts the channel (eg, the spring 1558 of FIG. 41). For example, it may be configured to open the proximal first passage 1416) in FIG.

The adapter assembly 1450 may include a passage (eg, a distal first passage 1246 and / or a distal second passage 1254 in FIG. 41). The passage can communicate fluid with the inner part of the container, such as a vial. The adapter assembly 1450 may include a second spring (eg, spring 1504 of FIG. 41) that is axially connected to the adapter seal (eg, second seal 1486 of FIG. 41). The second spring may be configured to move the adapter seal to seal the adapter passage.

42-45 illustrate various configurations and diagrams of syringe assembly 1402 and adapter assembly 1450. FIG. 42 illustrates the syringe assembly 1402 of FIG. 41 mechanically and fluidly coupled to the adapter assembly 1450 of FIG. 41. FIG. 43 illustrates the syringe assembly 1402 of FIG. 41 that is mechanically and fluidly disconnected from the adapter assembly 1450 of FIG. 41. FIG. 44 illustrates a close-up view of a syringe assembly 1402 mechanically and fluidly coupled to an adapter assembly 1450. FIG. 45 illustrates a close-up view of the syringe assembly 1402 mechanically and fluidly disconnected from the adapter assembly 1450. To make the syringe assembly 1402 and adapter assembly 1450 more obvious, all features, components, and assemblies of FIGS. 42-45 are not numbered.

FIG. 46 illustrates a method of fluidly connecting a syringe to an adapter according to some embodiments. This method can be used with any of the syringe systems and adapters described herein. Block 1600 may include opening, opening, and / or opening a first passage of the adapter. The first passage may be configured to allow fluid communication between the first reservoir and the vessel. The first passage can be a gas passage. Then referring to FIG. 36A, the first passage of the adapter can be a first distal passage 1246, with a radial protrusion 1508 of the second seal 1486 in the medial tapered region 1518 of the adapter assembly 1450. It can be opened, opened, and / or opened by moving the radial protrusion 1508 distally so that it does not come into contact.

Block 1604 in FIG. 46 may include opening, opening, and / or opening the first passage of the syringe. The first passage of the syringe may be configured to communicate fluidly with the first passage of the adapter to form a first passage (eg 220 in FIG. 7) between the first reservoir and the vessel. Then referring to FIG. 39, the first passage of the syringe can be the proximal first passage 1416, with a third seal 1562 (as shown in FIG. 38) sealing against the inner surface 1580. As such, by moving the third seal 1562 distally, it can be sealed, obstructed, and / or closed. Proximal first passage 1416 is where the syringe assembly 1402 is connected to the adapter so that the adapter pushes the distal portion 1584 of the passage shaft 1574 in the proximal direction, and the third seal 1562 seals, obstructs. Moving from the and / or closed position to the open, open, and / or open position may open, open, and / or open.

Block 1608 of FIG. 46 may include opening, opening, and / or opening a second passage of the syringe. The second passage may be configured to allow fluid communication between the second reservoir and the container. The second passage can be a liquid passage and / or can be configured to allow fluid communication from a container such as a vial. Then, referring to FIGS. 38 and 39, the second passage of the syringe can be the proximal second passage 1424. FIG. 38 illustrates a second passage 1424 proximal to the sealing, obstructing, and / or closed position. FIG. 39 illustrates a second passage 1424 proximal to the open, open, and / or open position. The distal portion 1584 of the passage shaft 1574 may include a tapered portion that seals, interferes, and / or closes with respect to the tapered portion 1548 of the distal cap 1550 in the sealing zone 1590.

In some embodiments, the proximal second passage 1424 comprises a "self-engaged" sealing system 1568. In some self-engagement embodiments, a sealing system, a flow control unit, and / Or increase the sealing force of the valve. The self-engagement sealing system 1568 may include a surface against which pressure applies the two sealing surfaces together to stiffen the seal. In some embodiments, the surfaces can be perpendicular to the direction of travel so that the sealing surfaces fit together tightly. In some embodiments, greater pressure on the working surface 1572 pushes the distal portion 1584 of the passage shaft 1574 towards the tapered portion 1584, increasing the sealing strength.

Block 1612 in FIG. 46 may include opening, opening, and / or opening a second passage of the adapter. The second passage of the adapter may be configured to communicate fluidly with the second passage of the syringe to form a second passage (eg, 224 in FIG. 7) between the second reservoir and the vessel. Next, referring to FIG. 36A, the second passage of the adapter can be the distal second passage 1254. FIG. 36A illustrates a distal second passage 1254 in the open, open, and / or open position, where the second seal 1486 is distal (rather than the proximal seal position 1502). Because in position, the second seal 1486 does not cover, seal, block, and / or interfere with the radial hole 1528. As a result, fluid (such as medical fluid) can flow through the distal second passage 1254 and through the radial hole 1528 into the proximal second passage 1424 (shown in FIG. 39).

As shown in FIG. 46, block 1600, block 1604, block 1608, and block 1612 can be implemented in any order. Some embodiments implement these blocks in a particular order. In some embodiments, block 1600 is implemented first, block 1604 is implemented second, block 1608 is implemented third, and block 1612 is implemented fourth. In some embodiments, opening the first passage of the adapter, then opening the first passage of the syringe, then opening the second passage of the syringe, then opening the second passage of the adapter. Including. Some embodiments include opening, opening, and / or opening the first passage before opening, opening, and / or opening the second passage, where the first passage is a gas. The second passage is configured to communicate with the liquid.

Some embodiments include fluid-connecting a container, such as a vial, to a gas reservoir before fluid-connecting the container, such as a vial, to a reservoir that is configured to contain a liquid, such as a drug fluid. Some embodiments include fluidly connecting a container, such as a vial, to a pressure equalizing reservoir prior to fluidly connecting the container to a reservoir configured to contain the drug fluid.

In some embodiments, the inner portion of the adapter is fluidly sealed against the inner portion of the syringe before performing at least one or all of blocks 1600, 1604, 1608, and 1612. Including. Next, referring to FIG. 41, the first seal 1470 can fluidly seal the inner portion of the adapter assembly 1450 with respect to the inner portion of the syringe assembly 1402. Thus, the syringe system has a proximal first passage 1416, a proximal second passage 1424, a distal first passage 1246, and / or distal (as shown in FIGS. 36A and 39). An internal isolation zone can be formed before opening the second passage 1254 of.

FIG. 47 illustrates a method of fluidly disconnecting a syringe from an adapter according to some embodiments. This method can be used with any of the syringe systems and adapters described herein. Block 1630 may include sealing, obstructing, and / or closing the second passage of the adapter. Block 1634 may include sealing, obstructing, and / or closing the second passage of the syringe. Block 1638 may include sealing, obstructing, and / or closing the first passage of the syringe. Block 1642 may include sealing, obstructing, and / or closing the first passage of the adapter.

Block 1630, block 1634, block 1638, and block 1642 can be implemented in any order. Some embodiments implement these blocks in a particular order. In some embodiments, block 1630 is implemented first, block 1634 is implemented second, block 1638 is implemented third, and block 1642 is implemented fourth. In some embodiments, the second passage of the adapter is sealed, obstructed, and / or closed, then the second passage of the syringe is sealed, obstructed, and / or closed, and then the syringe first. Includes sealing, obstructing, and / or closing one passage, and then sealing, obstructing, and / or closing the first passage of the adapter. In some embodiments, prior to sealing, obstructing, and / or closing the first passage (which may be a passage configured to allow the gas to communicate and / or equalize the pressure in the vessel). Includes sealing, obstructing, and / or closing a second passage (which may be a passage configured to communicate the drug fluid). Some embodiments include sealing, obstructing, and / or closing the first passage before sealing, obstructing, and / or closing the second passage.

Some embodiments include performing at least one or all of blocks 1630, 1634, 1638, and 1642, and then fluidly opening the inner portion of the adapter from the inner portion of the syringe. Next, referring to FIG. 41, the first seal 1470 can fluidly open the inner portion of the adapter assembly 1450 from the inner portion of the syringe assembly 1402. Thus, the syringe system has a proximal first passage 1416, a proximal second passage 1424, a distal first passage 1246, and / or distal (as shown in FIGS. 36A and 39). After closing the second passage 1254, the internal isolation area can be opened, opened, and / or opened.

FIG. 48 illustrates a perspective view of another embodiment of the pressure regulating syringe system 1700 just before the syringe assembly 1704 is connected to the adapter assembly 1708. The adapter assembly 1708 may include a penetration member 1712. System 1700 may be the same as or identical to any of the other pressure regulating syringe systems described herein and may include any of the features of such other systems. As shown, the syringe assembly 1704 may include a plunger 1740 and a distal cap 1744. The plunger 1740 may include a finger grip 1752. While some embodiments described herein use a manual plunger, each embodiment can use a pneumatic syringe and / or a pneumatic plunger.

Syringe system 1700 may include an outer fluid access port such as valve 1716. The valve 1716 may have an open position and a closed position. When in the open position, the valve 1716 encirculates the pressure inside the vessel as gas (such as ambient air 244) located outside the syringe system 1700 enters the first passage and / or the first reservoir. It can be tolerated to facilitate equalization with pressure. Valve 1716 may include a cap 1720 that covers the inlet of the first passage. In some embodiments, the user can open the cap 1720 by pulling one side of the cap 1720 away from the barrel 1724 with a finger. The valve 1716 may include a filter 1728 that filters the gas that flows into or out of the valve 1716. Valve 1716 may include a cap that is configured to allow the user to "flip" into the open position with the thumb. Valves 1716 include pinch valves, duck bill valves, check valves, butterfly valves, one-sided valves, ball valves, membrane check valves, swing check valves, tilted disc check valves, stop check valves. , Lift check valves, in-line check valves, and / or two-way valves.

Some other embodiments do not include an outer fluid access port. For example, as illustrated, a number of other embodiments disclosed herein do not include outer fluid access ports. Some embodiments that do not include an outer fluid access port are configured not to use an external (eg, ambient) fluid as the conditioning fluid. For example, in various embodiments that do not include an outer fluid access port, the external fluid is not used as a conditioning fluid even after the liquid has been injected into and / or drawn from a flexible container (eg IV bag).

FIG. 49 illustrates a cross-sectional perspective view along line 49-49 of FIG. 48 when the syringe assembly 1704 is connected to the adapter assembly 1708. The syringe assembly 1704 may include a first reservoir 1760 that has been separated from the second reservoir 1764 by a distal plunger seal 1768. The distal plunger seal 1768 may be connected to the distal end of the plunger 1740. The proximal end of the first reservoir 1760 can be sealed by the proximal seal 1772. The plunger 1740 can slide through the central lumen of the proximal seal 1772. The first passage 1776 may be configured to allow fluid communication of the first reservoir 1760 with a container, such as a container configured to contain the drug. A second passage 1780 may be configured to allow the second reservoir 1764 to communicate fluidly with the container. The barrel 1724 (which can be a housing) may include an internal channel 1778 having a diameter.

FIG. 50 illustrates a cross-sectional perspective view of the adapter assembly 1708 of FIG. 48 in which the plunger 1740 and the distal plunger seal 1768 have been moved to the distal position. In this figure, the adapter assembly 1708 is in close proximity to the syringe assembly 1704 but not connected to the syringe assembly 1704.

The syringe assembly 1704 may include a proximal first passage 1800 configured to fluidly connect with a first distal passage 1856 of the adapter assembly 1708. The distal opening 1804 may allow fluid to flow from a portion of the proximal first passage 1800 into the open area 1888 within the distal portion of the syringe assembly 1704. Open area 1888 may be sealed, obstructed, and / or closed by a third seal, which may be an O-ring. When the syringe assembly 1704 is removed from the adapter assembly 1708, a third seal 1870 seals against the inner surface 1828, sealing, obstructing, and / or closing the proximal first passage 1800. This prevents the air disposed in the first reservoir from leaking out of the syringe assembly 1704.

The passage shaft 1808 can move distally and / or proximally because the fourth seal 1844 can slide the passage shaft 1808 within the lumen of the fourth seal 1844. An urging member, such as a spring 1824, pushes the aisle shaft 1808 distally. The adapter assembly 1708 can overcome the spring force of the spring 1824 and push the passage shaft 1808 to the proximal position when the syringe assembly 1704 is connected to the adapter assembly 1708, resulting in the engagement of the third seal 1870. Disengaged to open, open and / or open the proximal first passage 1800 and / or a sealing zone 1854 (in a dashed rectangle) between the passage shaft 1808 and the distal portion of the syringe assembly 1704. ) Will be disengaged to open, open, and / or open the proximal second passage 1832.

In some embodiments, when the syringe assembly 1704 is connected to the adapter assembly 1708, a protrusion 1816 that projects radially inward from the flexible arm 1820 is placed in the groove 1812 to form the syringe assembly. It is useful for fixing the solid 1704 to the adapter assembly 1708. Some embodiments include threads for mechanically connecting the syringe assembly 1704 to the adapter assembly 1708 (see, eg, FIGS. 25 and 26).

As illustrated in FIG. 50, the adapter assembly 1708 may include a second distal passage 1848 and a first distal passage 1856. A portion of the distal second passage 1848 and a portion of the distal first passage 1856 may be located within the penetration member 1852. The distal second passage 1848 is configured to fluidly connect to the proximal second passage 1832 when the syringe assembly 1704 is mechanically and / or fluidly connected to the adapter assembly 1708. Can be done. The distal first passage 1856 is configured to fluidly connect to the proximal first passage 1800 when the syringe assembly 1704 is mechanically and / or fluidly connected to the adapter assembly 1708. Can be done. The first passage is fluidly isolated and separated from the second passage when the syringe assembly 1704 is not connected to the adapter assembly 1708 and / or when the syringe assembly 1704 is connected to the adapter assembly 1708. / Or can be sealed.

A second seal 1874 may be configured to seal against the inner tapered region 1890. An urging member, such as a spring 1836, may push the second seal 1874 proximally. When the syringe assembly 1704 is connected to the adapter assembly 1708, the spring 1836 contracts to open, open, and / or open the distal first passage 1856 and the distal second passage 1848.

As shown in FIG. 50, when the syringe assembly 1704 is not connected to the adapter assembly 1708 (eg, when separated from the adapter assembly 1708), according to some embodiments, the first seal 1878 It is in the open, open, and / or open position. In some embodiments, when the syringe assembly 1704 is not connected to the adapter assembly 1708, the second seal 1874 provides a distal second passage 1848 and / or a distal first passage 1856. Seal, block, and / or close.

FIG. 51 illustrates a cross-sectional perspective view of the adapter assembly 1708 along lines 49-49 of FIG. 48 when the adapter assembly 1708 is connected to the syringe assembly 1704. As shown, according to some embodiments, the sealing zone 1854 is opened, opened, and / or opened when the syringe assembly 1704 is connected to the adapter assembly 1708. The first seal 1878 is in the sealing, obstructing, and / or closed position in FIG.

As shown in FIG. 51, the second seal 1874 may seal the transition between the proximal second passage 1832 and the distal second passage 1848. In some embodiments, the second seal may also allow fluid communication between the proximal second passage 1832 and the distal second passage 1848. In some embodiments, the second seal 1874 may allow fluid communication between the proximal first passage 1800 and the distal first passage 1856. In FIG. 51, the second seal 1874 seals and / or interferes with fluid communication between the first passage and the second passage.

52 and 53 illustrate side sectional views of another embodiment of a syringe assembly 1900 having a bag 1908 arranged within a housing. The system shown in FIGS. 52 and 53 may be the same as or identical to any of the other pressure regulating syringe systems described herein and may include any of the features of such other systems. Next, referring to FIG. 52, the syringe assembly 1900 may include a bag 1908, the bag 1908 being illustrated in a collapsed and bent configuration. The inner portion of the bag 1908 includes a first reservoir 1904 configured to fluidly connect to the inner portion of the container via a proximal first passage 1416. The bag 1908 may be located inside the syringe assembly 1900 and inside the plunger 1404. The bag 1908 may fluidly separate the first reservoir 1904 from the third reservoir 1912 (eg, the peripheral portion). The third reservoir 1912 may have fluid communication with ambient air via vents 1436, holes, valves, and / or filters. In some embodiments, the vent 1436 is located within the proximal portion of the plunger 1404.

FIG. 53 illustrates a bag 1908 in an expanded and open configuration. In some embodiments, the bag 1908 does not stretch when expanded, but the internal volume of the bag 1908 increases as the bag expands (eg opens). The internal volume of the bag 1908 is larger in FIG. 53 than in FIG. 52. The volume of the third reservoir 1912 is smaller in FIG. 53 than in FIG. The surface area of bag 1908 in FIG. 53 is equal to (or at least approximately equal to) the surface area of bag 1908 in FIG. In some embodiments, the surface area of the expanded bag is within +/- 5%, +/- 10%, or +/- 20% of the surface area of the crushed bag, and the bag is expanded and / or expanded. It is configured so that it does not substantially stretch during normal operating conditions. In some embodiments, the material of the bag does not make the bag resilient. In some practices, as the bag 1908 expands (eg, the internal volume increases), the bag 1908 stretches and / or imparts restoring force to the fluid within the bag 1908.

FIG. 54 illustrates a cross-sectional view of an embodiment of a pressure regulating syringe system 2000 having an auxiliary reservoir 2004 that may be configured to provide additional volume to the first reservoir 712. System 2000 may be the same as or identical to any of the other pressure regulating syringe systems described herein and may include any of the features of such other systems. The auxiliary reservoir 2004 may have a rigid wall and may be located outside the barrel 390 and / or the plunger 720. Auxiliary reservoir 2004 is at least 50% of the volume of the first reservoir 712 and / or 300 of the volume of the first reservoir 712 (as measured at the maximum possible volume of the first reservoir 712 under normal operating conditions). Can have an internal volume of less than%. The auxiliary reservoir 2004 may have an internal volume of at least 110% of the volume of the first reservoir 712 and / or less than 500% of the volume of the first reservoir 712. The auxiliary reservoir 2004 may have an internal volume of at least 200% of the volume of the first reservoir 712 and / or less than 900% of the volume of the first reservoir 712. As illustrated in various embodiments, the sum of the maximum volumes of the auxiliary reservoir and the first reservoir can be greater than the maximum volume of the second reservoir.

Valve 704 may control (eg, interfere with) fluid communication between the first reservoir 712 and the auxiliary reservoir 2004. Auxiliary reservoir 2004 may be used when the healthcare professional determines that additional gas and / or volume is required, desirable, and / or beneficial to regulate the pressure in the vessel 304. The auxiliary reservoir 2004 may be connected to the pressure regulating syringe system 2000, to the barrel 390, and / or to the plunger 720 by thread. In some embodiments, the auxiliary reservoir 2004 can communicate fluidly with the first reservoir 712. In some embodiments, the fluid is moved from the second reservoir 312 to the vessel 304 and / or from the vessel 304 to the second before the auxiliary reservoir 2004 communicates with the first reservoir 712 and / or the vessel 304. Includes moving to reservoir 312.

FIG. 55 illustrates a cross-sectional view of an embodiment in which the auxiliary reservoir 2020 includes a bag 2008 that may be placed inside the wall 2012. The system illustrated in FIG. 55 may be the same as or identical to any of the other pressure regulating syringe systems described herein and may include any of the features of such other systems. The wall 2012 can be rigid. Vent 2016 may allow ambient air to enter the auxiliary reservoir 2020. Since the bag 2008 can fluidly seal the first reservoir 712 from the ambient air, the ambient air does not come into contact with the inner surface of the bag 2008. In various embodiments, ambient air can contact the outer surface of the bag 2008.

FIG. 56 illustrates a cross-sectional view of an embodiment in which the auxiliary reservoir 2024 includes a bag 2008 connected to a barrel 390. In some embodiments, the bag 2008 is not and / or is not surrounded by a rigid wall.

57-59 illustrates a seal having a rigid inner body and a compliant sealing member configured to fluidly seal the inner surface of the plunger. The responsive sealing member may be placed around at least a portion of the rigid inner body. The seals of FIGS. 57-59 can be used with any of the systems or components described herein. The seals of FIGS. 57-59 can be used in place of the other proximal plunger seals described and / or exemplified herein.

FIG. 57 illustrates a side view of the proximal plunger seal 2040, in which a seal such as a gasket, rubber protrusion, or O-ring 2044 is partially in the groove around the outer diameter of the proximal plunger seal 2040. It is located in. The O-ring 2044 can be made from a compliant rubber material. Some embodiments include an O-ring 2044 made of medical grade silicone or neoprene. Some embodiments include at least two O-rings connected to a rigid carrier 2048 that can be made of molded plastic and / or machined. In some embodiments, the carrier 2048 is molded and then machined (eg, deburred on a lathe or grinding machine) to remove the mating streaks and the O-ring 2044 seals against the outer surface of the carrier 2048. It is easy to stop.

The distal portion may contain one seal (eg, O-ring 2044) and the proximal portion may contain one seal (eg, O-ring 2044). Some embodiments include three or more seals. One or both ends of carrier 2048 may include a rounded or chamfered edge 2052 to prevent hooking (eg, tearing) on the inner surface of a plunger (eg, 1404 in FIG. 30). The carrier may be configured to prevent the proximal plunger seal 2040 from tilting.

In some embodiments, the first seal (eg, O-ring 2044) is at least 0.5 cm, 0.75 cm, or 1 cm away from the second seal (eg, O-ring 2044). In some embodiments, the outer diameter of the carrier 2048 is at least 80% and / or less than 99% of the inner diameter of the plunger in which the carrier 2048 is located. In some embodiments, the outer diameter of the carrier 2048 is at least 90% and / or less than 98% of the inner diameter of the plunger in which the carrier 2048 is located.

FIG. 58 illustrates a side view of the proximal plunger seal 2060, in which the wiper seal 2064 is partially located in a groove around the outer diameter of the proximal plunger seal 2060. The wiper seal 2064 can be made from medical grade silicone or neoprene. The wiper portion of the wiper seal 2064 may extend radially outward from the carrier 2068. One wiper seal 2064 may be placed in the distal portion of carrier 2068 and one wiper seal 2064 may be placed in the proximal portion of carrier 2068. In some embodiments, the first wiper seal 2064 is at least 0.5 cm, 0.75 cm, or 1 cm away from the second wiper seal 2064. In some embodiments, the outer diameter of the carrier 2068 is at least 80% and / or less than 99% of the inner diameter of the plunger in which the carrier 2068 is located. In some embodiments, the outer diameter of the carrier 2068 is at least 90% and / or less than 98% of the inner diameter of the plunger in which the carrier 2068 is located.

FIG. 59 illustrates a side view of the proximal plunger seal 2080, in which one wiper seal 2084 is partially located in a groove around the outer diameter of the proximal plunger seal 2080. The groove can be part of the carrier 2088 and can be configured to secure and / or accommodate a seal such as the wiper seal 2084. The carrier 2088 may include a first diameter and a second diameter. One seal (eg, wiper seal 2084, O-ring) may project radially outward from a portion of carrier 2088 that includes a first diameter 2092. The second diameter 2096 can be made larger than the first diameter 2092 and can be separated from a portion of the proximal plunger seal 2080 that includes the seal (eg, wiper seal 2084). The second diameter 2096 can be a support surface configured to limit the range in which the proximal plunger seal 2080 can tilt within the plunger. The second diameter 2096 can be smaller than the outer diameter of the seal (eg, wiper seal 2084). Since the second diameter 2096 can be made from a rigid material, it is possible to form a rigid support surface configured to limit the range in which the proximal plunger seal 2080 can tilt within the plunger. In some embodiments, the outer diameter of the seal is greater than the second diameter and the second diameter is greater than the first diameter.

FIG. 60 illustrates a side sectional view of the pressure adjusting syringe system 2100. The system 2100 may be the same as or identical to any of the other pressure regulating syringe systems described herein and may include any of the features of such other systems. The pressure regulating syringe system 2100 includes a seal 2104, which can be a wiper seal with multiple wipers. The seal 2104 forms a proximal boundary of the first reservoir 2108, which is configured to allow a fluid such as gas to communicate through the first passage 816 to and / or from the inner portion 810 of the container 304. obtain. Since the seal 2104 can be slidably coupled within the pressure adjusting syringe system 2100, the seal 2104 slides within a portion of the pressure adjusting syringe system 2100 to change the volume of the first reservoir 2108. Can be done.

The pressure regulating syringe system 2100 may include a second reservoir 2116 configured to allow a fluid, such as a liquid, to communicate with and / or from the inner portion 810 of the container 304 through the second passage 826. .. As illustrated in FIGS. 60 and 61, the longitudinal axes of the first and second reservoirs may be offset and not collinear in some embodiments. Also, as illustrated, the longitudinal axes of the first and second reservoirs can be approximately parallel. The plunger seal 2112 may form the proximal boundary of the second reservoir 2116. The plunger seal 2112 is configured on the plunger 720 to allow and / or allow the user to change the volume of the second reservoir 2116 by pushing into and / or pushing out of the pressure regulating syringe system 2100. Can be linked. The first reservoir 2108 and the second reservoir 2116 can be next to each other. In some embodiments, the first side of the pressure regulating syringe system 2100 comprises a first reservoir 2108 and the second side of the pressure regulating syringe system 2100 comprises a second reservoir 2116. The first reservoir 2108 and / or the second reservoir 2116 can be cylindrical and / or generally cylindrical.

Stops 2120 and 2124 may limit the movement of the seal 2104 and plunger 720 to prevent and / or reduce the possibility of the seal 2104 and plunger 720 being inadvertently disconnected from the pressure regulating syringe system 2100. The stops 2120 and 2124 may be protrusions that project inward in the radial direction and interfere with a portion of the seal 2104 and / or plunger 720 when the seal 2104 and / or plunger 720 reaches the proximal movement end point. The stops 2120 and 2124 may be located relative to the seal 2104 and / or the plunger seal 2112.

FIG. 61 illustrates a pressure regulating syringe system 2100 after the seal 2104 has moved distally and the plunger 720 has moved proximally. The seal 2104 and the plunger 720 (including, for example, the plunger seal 2112) can slide within the pressure regulating syringe system 2100. In some embodiments, the seal 2104 and plunger 720 are configured to slide distally and proximally within the pressure regulating syringe system 2100.

The syringe assembly can be connected to a vial adapter and / or to other fluid transfer connectors. For example, a healthcare professional may connect a syringe assembly to a container that is not a vial. In some cases, the syringe assembly is used to remove the drug from a container such as a vial and then to inject the drug into a peripheral, arterial, and / or central venous catheter. The syringe assembly can be used to deliver the pharmaceutical substance to an intravenous therapy (“IV”) bag or IV line. In some embodiments, the syringe assembly is mechanically and fluidly coupled to a Clave® needle-free connector commercially available from ICU Medical.

FIG. 62 illustrates a cross-sectional view of the syringe assembly 1402 and connector 2200 of FIG. 38. In FIG. 62, the syringe assembly 1402 is not connected to the connector 2200. Connector 2200 may be configured to mechanically and fluidly connect to tubes, cannulas, containers, and / or bags.

The connector 2200 may include a distal second passage 2204 that is configured to be fluid-communication with and / or fluid-communication with the proximal second passage 1424 of the syringe assembly 1402. The proximal portion of the distal second passage 2204 may be sealed by a second seal 2208, such that the second seal 2208 covers the connector proximal aperture 2212 of the distal second passage 2004. It can be configured and can be configured to provide a substantially liquid-tight seal of the connector proximal aperture 2212. In some embodiments, the connector proximal aperture 2212 may be directed radially outward from the central axis of the distal second passage 2204. In some embodiments, the connector proximal aperture 2212 can be the aperture, hole, and / or exit of the passage (eg, the distal second passage 2204).

The second seal 2208 may include a sealing surface 2216 facing proximally. In some embodiments, during connection of the syringe assembly 1402 and the connector 2200, the sealing surface 2216 is directed to the distal end 2220 of the syringe assembly 1402 and / or the proximal second passage 1424. The sealing surface 2216 can also be oriented proximally relative to the connector 2200. In some embodiments, the second seal 2208 is a boot seal. The second seal 2208 can be made from rubber or medical grade silicone. In various practices, the second seal 2208 can elastically collapse (eg, distally) in the axial direction.

In FIG. 62, the second seal 2208 is shown in a fully extended position. As detailed below, the syringe assembly 1402 compresses the second seal 2208 distally to expose the connector proximal aperture 2212, thereby opening the distal second passage 2204. And / or the distal second passage 2204 is configured to fluidly communicate with the proximal second passage 1424.

FIG. 63 illustrates the connector 2200 during the initial contact step with the syringe assembly 1402. In some embodiments, the sealing surface 2216 seals against at least a portion of the distal end 2220 of the syringe assembly 1402 during this initial contact step (and subsequent contact step). Sealing zone 1590 is still in a closed and sealed configuration in FIG.

Syringe assembly 1402 may include threaded portion 1556. The threaded portion 1556 may be coupled with the threaded portion 1586 of the connector 2200 to provide threaded engagement. Threaded portions 1556, 1586 transmit rotational movement to axial movements such as distal or proximal movements.

FIG. 64 illustrates a connector 2200 partially connected to a syringe assembly 1402. In some embodiments, the connector 2200 and the syringe assembly 1402 are connected. For example, the connector 2200 and the syringe assembly 1402 may include corresponding threads, which may facilitate mechanical connection. In some embodiments, when the connector 2200 is advanced into the syringe assembly 1402, the proximal end 2224 of the push member (such as a shaft or protrusion) engages (eg, is pressed) with the distal portion 1584. As a result, a proximal force can be generated, which can compress the spring 1558. This movement can open the sealing zone 1590 (as shown in FIG. 64). The sealing zone 1590 can be in the open position, the distal second passage 2204 can communicate with the proximal second passage 1424, but the third seal 1562 is still (as illustrated in FIG. 64). Can be in a closed position. The closed position of the third seal 1562 may interfere with and / or prevent fluid communication between the proximal first passage 1416 and the connector 2200.

FIG. 65 illustrates a connector 2200 connected to a syringe assembly 1402. As the proximal end 2224 continues to engage (eg, push) the distal portion 1584, the second seal 2208 is compressed (the spring 1558 is compressed) and the second seal 2208 engages the connector proximal aperture 2212. The connector proximal aperture 2212 is opened by being moved to a position where it is no longer sealed (eg, not covered). The opening of the connector proximal aperture 2212 allows the distal second passage 2204 to fluidly communicate with the proximal second passage 1424 and / or the second reservoir 1444. Thus, in some embodiments, fluid can flow between the second reservoir 1444 and the connector 2200 (eg, the inner portion of the connector, such as the distal second passage 2204). The sealing surface 2216 is configured to prevent leakage of fluid flowing between the proximal second passage 1424 and the distal second passage 2204.

In some embodiments, the proximal movement of the sliding member 1576 and / or compression of the spring 1558 (which may be any type of spring or compression member) described above causes the third seal 1562 to move proximally. .. This proximal movement may prevent the third seal 1562 from contacting (or otherwise sealing) the inner surface 1580. When the third seal 1562 no longer contacts the inner surface 1580, the third seal 1562 no longer seals the proximal first passage 1416 (eg, in the open position).

In one embodiment, when the third seal 1562 is in the open position, the proximal first passage 1416 opens. For example, as shown in FIG. 65, the seal 1562 is separated from the inner surface 1580 so that fluid can flow between the seal 1562 and the inner surface 1580. This allows access to the proximal first passage 1416 so that fluid can flow into and / or out of the passage 1416.

In some embodiments, connecting the syringe assembly 1402 to the connector 2200 does not open the proximal first passage 1416, but connecting the syringe assembly 1402 to the vial adapter does not open the proximal first passage 1416. 1416 is opened. This may allow the syringe assembly 1402 to allow fluid communication into and out of a container such as a vial. In some embodiments, the connector 2200 provides a distal first passage (eg, 1246 in FIG. 41) configured to direct fluid from the container to and / or from the syringe assembly 1402. If not, connecting the connector 2200 to the syringe assembly 1402 will not open and / or open the proximal first passage.

Connecting the connector 2200 to the syringe assembly 1402 can form a sealing zone 2230 that seals and / or interferes with the proximal first passage 1416, so that the first reservoir 1420 (shown in FIG. 40). Fluid (eg, gas) from does not leak from the syringe assembly 1402 and / or into ambient air 244 located outside the syringe assembly 1402 and outside the connector 2200. The sealing zone 2230 can be formed by any suitable seal, including the fitting threads of the connector 2200 and syringe assembly 1402. In the embodiment illustrated in FIG. 65, each frame formed by the dashed line indicates an area with a fitting thread that prevents or prevents fluid from exiting the proximal first passage 1416. Some embodiments include a sealing zone 2230 that prevents fluid transfer by means of a seal (eg, an O-ring, gasket, or the like) in addition to, or instead of, a mating thread. Some fitting thread embodiments use plastics that provide sufficient responsiveness to form a gas seal and / or a nearly airtight seal between the fitting threads. The proximal first passage 1416 of FIG. 65 includes a relatively large open area 2234 that can be sealed by a third seal 1562 and / or by a sealing zone 2230.

In some embodiments, the connector 2200 is a fluid (eg, in a container that can be located distal relative to the connector 2200) through the connector 2200 from the first reservoir 1420 (shown in FIG. 40). It does not include a distal first passage 1246 (shown in FIG. 41) that is configured to deliver (gas). Some connectors 2200 include a passage for sending a fluid (eg, liquid) from the second reservoir, but not a passage for sending a fluid (eg, gas) from the first reservoir. In some embodiments, the connector includes a passage for delivering fluid from the second reservoir but not a passage for delivery of fluid from the first reservoir, the syringe assembly 1402 requires a change in volume of the first reservoir. It can be configured so that the volume of the second reservoir can be changed without. As mentioned above, this can be called volume independence. The volumetric independence of the first reservoir from the second reservoir can reduce or prevent the pressure from deviating significantly from atmospheric pressure.

For example, in some embodiments, the first reservoir is not volumetrically independent of the second reservoir (eg, when the syringe assembly 1402 is connected to the connector 2200) and is proximal to the first. If the passage 1416 is sealed, the fluid is sent from the second reservoir 1444 through the connector 2200, and the proximal first passage 1416 sends the fluid into the first reservoir to provide the first The pressure in the reservoir cannot be adjusted, which can lead to an increase in volume in the first reservoir. As a result, the pressure in the first reservoir can be lower than atmospheric pressure (eg, forming a "negative pressure"). In another example, the first reservoir is not volumetrically independent of the second reservoir (eg, when the syringe assembly 1402 is connected to the connector 2200) and the proximal first passage 1416 When sealed, when fluid is fed through the connector 2200 to the second reservoir 1444, the proximal first passage 1416 pumps the fluid out of the first reservoir to reduce the pressure in the first reservoir. Unable to adjust, the volume in the first reservoir can be reduced. As a result, the pressure in the first reservoir can be higher than atmospheric pressure (eg, forming an "overpressure").

Returning to FIG. 40, in some embodiments, the first reservoir 1420 and the second reservoir 1444 are volumetrically independent for at least one of several reasons. The first reservoir 1420 and the second reservoir 1444 are located in separate housings (eg, separate cylinders). Moving the plunger distally or proximally can change the volume of the second reservoir 1444, but not necessarily the volume of the first reservoir 1420. As mentioned above, in some embodiments, the volume of the first reservoir 1420 can change as the proximal plunger seal 1412 moves (eg, slides) within the plunger 1404 due to the pressure gradient. Thus, in some embodiments, the volume of the first reservoir 1420 changes in response to a pressure gradient rather than in response to changes in the volume of the second reservoir 1444.

Fluid connection of the syringe assembly 1402 to the adapter assembly 1450 and container can result in a closed volume system. In a closed volume system, the system is sealed from ambient air so that the volume of the system remains largely constant and / or unchanged (at least until the seal begins to leak) during normal operation. In some embodiments, if the container has a fixed volume (eg, due to a rigid wall), a decrease in the volume of the second reservoir 1444 will typically increase the volume of the first reservoir 1420. This is because when the fluid is sent from the second reservoir 1444 to the container, the fluid in the container can be expelled and the expelled fluid can be sent into the first reservoir 1420. Similarly, if the container has a fixed volume (eg, due to a rigid wall), increasing the volume of the second reservoir 1444 will typically decrease the volume of the first reservoir 1420. This is because when the fluid is sent from the container to the second reservoir 1444, the pressure in the container can be reduced, whereby the fluid in the first reservoir 1420 can be sent into the container to adjust the pressure.

A closed volume system with a container with a variable volume (eg, due to a flexible wall) can behave differently than a closed volume system with a container with a fixed volume. A glass vial is an example of a container with a rigid wall and a fixed volume. The IV bag is an example of a container with flexible walls and variable volume. The volume of the IV bag can vary depending on how much fluid is delivered into or out of the IV bag.

In some embodiments, if the container has a variable volume (eg, due to a flexible and / or compliant wall), even if the volume of the second reservoir 1444 is reduced, it is typically the first. The volume of the reservoir 1420 is not increased. This is because the decrease in the volume of the second reservoir 1444 does not necessarily increase the pressure in the first reservoir 1420. The pressure in the first reservoir 1420 can remain largely constant (eg, not increased), except for the restoring force given by the container itself, such as the compressive restoring force of an inflated latex balloon. This is because feeding the fluid from the second reservoir 1444 to a variable volume vessel typically results in an increase in the volume of the vessel, rather an increase in pressure within the vessel (hence the fluid). It is easy to be pulled from the container to the first reservoir 1420). Typically, the proximal plunger seal 1412 does not need to move to adjust the pressure unless the pressure in the first reservoir 1420 increases. Thus, the plunger seal 1412 can remain substantially stationary (eg, relative to the plunger body).

Similarly, if the vessel has a variable volume (eg, due to a flexible and / or compliant wall), even if the volume of the second reservoir 1444 increases, it will typically be of the first reservoir 1420. The volume does not decrease. This is because feeding fluid from a variable volume container to the second reservoir 1444 typically reduces the volume inside the container rather than the pressure inside the container. As a result, the pressure gradient (which would otherwise draw fluid from the first reservoir 1420 into the vessel) is reduced or prevented.

Containers with a fixed volume are configured such that the volume varies from 0% to 15% under normal operating conditions. For example, the volume of glass or plastic vials does not change substantially. Containers with variable volumes are configured to vary in volume by at least 50% under normal operating conditions. For example, an IV bag can start with a volume of approximately 10 milliliters, but can expand to a volume of approximately 100 milliliters. Other IV bags have different typical expansion ranges.

The container with a fixed volume can be a variable pressure vessel. In other words, if the volume of the container is fixed, the pressure of the gas in the container can change by removing the fluid from the container and adding the fluid to the container. The container having a variable volume can be a constant pressure container. In other words, if the volume of the container is variable, by removing the fluid from the container and adding the fluid to the container, the pressure of the gas in the container is typically (the volume of the container is the minimum or maximum volume of the container). Does not change significantly (unless it reaches). The IV bag is an example of a constant pressure container. Adding a fluid to the IV bag can increase the pressure exerted on the bag due to this fluid, but typically the addition of fluid does not change the pressure inside the IV bag. This is because the volume of the IV bag can be increased or decreased to reach equilibrium with atmospheric pressure.

FIG. 66 illustrates a side view of the syringe assembly 1402 connected to the IV bag 2250. The connector 2200 may fluidly and mechanically connect the syringe assembly 1402 to the IV bag 2250. Syringe assembly 1402 can deliver fluid to and / or from IV bag 2250. In some embodiments, the IV bag 2250 is a responsive container. Due to the responsiveness of the IV bag 2250, the internal pressure of at least a portion of the IV bag 2250 can be approximately equal to atmospheric pressure. In some embodiments, the syringe assembly 1402 reduces the pressure in the first reservoir below atmospheric pressure by less than 10%, without reducing it below atmospheric pressure by 5%. To deliver a fluid (eg, liquid) from the second reservoir to the inner portion of the IV bag without causing it to drop below 20% at atmospheric pressure or below 35% at atmospheric pressure. Can be configured.

Some embodiments include reducing the volume of the second reservoir without reducing the volume of the first reservoir. Some embodiments include reducing the volume of the second reservoir by at least 50% without reducing the volume of the first reservoir by more than 10%. Some embodiments include reducing the volume of the liquid reservoir by at least 50% without reducing the volume of the gas reservoir by more than 10%. In some embodiments, without reducing the volume of the gas reservoir located within the syringe assembly (eg, without reducing it at all, substantially without reducing it, and without reducing it by more than 10%). Includes sending liquid from the syringe assembly to the IV bag. In some embodiments, without reducing the volume of the gas reservoir located within the syringe assembly (eg, without reducing it at all, substantially without reducing it, and without reducing it by more than 10%). Includes sending liquid from the IV bag to the syringe assembly.

Some embodiments include removing the liquid from a rigid container (eg, vial) and placing a gas in the rigid container to reduce the pressure difference between the pressure in the container and the ambient pressure. Some embodiments include placing the liquid in a responsive container without removing the gas from the responsive container (eg, bag, IV bag).

FIG. 67 illustrates a method of transferring a liquid from a first container to a second container according to some embodiments. This method can be used with any of the syringe systems, syringe assemblies, and adapter assemblies described herein. The method may include obtaining a syringe assembly having a first reservoir and a second reservoir. Block 2300 may include connecting the syringe assembly to a first container having a fixed volume. Block 2304 may include sending liquid from a first container having a fixed volume to a second reservoir while increasing the volume of the second reservoir and decreasing the volume of the first reservoir. Reducing the volume of the first reservoir may include sending gas from the first reservoir to the first container to regulate the pressure in the container.
Block 2308 may include disconnecting the syringe assembly from a first container having a fixed volume. Decoupling can include mechanical and / or fluid decoupling. Decoupling may include sealing the first passage of the syringe assembly leading to the first reservoir. Decoupling may include sealing the second passage of the syringe assembly leading to the second reservoir. Decoupling may include sealing the first passage (eg, gas passage) before sealing the second passage (eg, liquid passage). Decoupling may include sealing a second passage (eg, a liquid passage) before sealing the first passage (eg, a gas passage). In some embodiments, the liquid reservoir is located relative to the gas reservoir. In some embodiments, the reservoir can contain gas and / or liquid.

Block 2312 may include connecting the syringe assembly to a second container having a variable volume. The second container can be a bag. The first container can be a vial such as a glass vial. Block 2316 may include delivering liquid from the second reservoir to the second container while reducing the volume of the second reservoir and maintaining the volume of the first reservoir. In some embodiments, block 2316 reduces the volume of the second reservoir by at least 50% and reduces the volume of the first reservoir by 10%, 20%, or less than 30%. It is replaced by sending the liquid from the second reservoir to the second container. In the context of changing block 2316, reducing volume by less than 10%, 20%, or 30% includes not reducing volume. In some embodiments, block 2316 reduces the volume of the second reservoir by at least about 50% and / or about 100% or less, at least about 20% and / or about 90% or less, at least about 70% and /. Or while reducing by about 100% or less, and reducing the volume of the first reservoir by 0% and / or by about 10% or less, at least about 5% and / or by about 20% or less, at least about 10% and / or It is replaced by sending liquid from the second reservoir to the second container, reducing by about 35% or less.

FIG. 68 illustrates a method of using a syringe assembly according to some embodiments. This method can be used with any of the syringe systems, syringe assemblies, and adapter assemblies described herein. The method may include obtaining a syringe assembly having a first reservoir and a second reservoir. Block 2350 may include connecting the syringe assembly to a first container. The connection may include mechanical and / or fluid connection.

Block 2354 may include sending (eg, collecting) a first liquid from a first container to a second reservoir. The first liquid can be, for example, physiological saline, sodium chloride solution, and / or sterile water. In some embodiments, the first liquid is fed from the first container to the second reservoir while maintaining the volume of the first reservoir (eg, in embodiments where the first container has a variable volume). May include. In some embodiments, the first liquid is sent from the first container to the second reservoir while reducing the volume of the first reservoir (eg, in embodiments where the first container has a fixed volume). May include.

Block 2358 may include disconnecting the syringe assembly from the first container. Decoupling can include mechanical and / or fluid decoupling. Block 2362 may include connecting the syringe assembly to a second container. The second container may contain drugs, formulations, medicines, and / or drugs. Drugs, formulations, pharmaceuticals, and / or drugs can be in powder form so that they can be reconstituted with diluents before being administered to a patient. The diluent can be physiological saline and / or sterile water. The drug can be in dry, freeze-dried, dehydrated, and / or lyophilized dosage forms.

As shown in FIG. 68, block 2366 may include sending (eg, introducing) a first liquid from a second reservoir to a second container. In some embodiments, block 2366 (eg, if the second container has a fixed volume) sends the gas from the container to the first reservoir while the first liquid from the second reservoir to the second container. May include sending to. In some embodiments, the block 2366 (eg, if the second vessel has a variable volume) maintains the volume of the first reservoir (eg, without changing the volume of the first reservoir). It may include sending one liquid from a second reservoir to a second container.

Block 2370 may include mixing at least a portion of the first liquid with at least a portion of a drug, formulation, drug, and / or drug placed in a second container. Block 2374 delivers at least a portion of the first liquid mixed with at least a portion of the drug from the second container to the second reservoir (eg, harvests) while delivering the gas from the first reservoir to the second container. ) Can be included. Block 2378 may include disconnecting the syringe assembly from the second container. Block 2382 may include connecting the syringe assembly to a third container, which can be either a fixed volume container or a variable volume container. In some embodiments, the third container is a bag, such as an IV bag.

Block 2386 comprises sending (eg, introducing) at least a portion of the first liquid mixed with at least a portion of the pharmaceutical product from the second reservoir to a third container while maintaining the volume of the first reservoir. obtain. In some embodiments, block 2386 is mixed with the pharmaceutical while reducing the volume of the second reservoir by at least 50% and the volume of the first reservoir by less than 10%. It is replaced by sending the liquid from the second reservoir to the third container. In some embodiments, block 2386 is mixed with the pharmaceutical while reducing the volume of the second reservoir by at least 90% and the volume of the first reservoir by less than 5%. It is replaced by sending the liquid from the second reservoir to the third container. In some embodiments, the block 2386 will send the first liquid mixed with the drug from the second reservoir to the third container without sending the gas from the third container to the first reservoir. Can be replaced. In some embodiments, the block 2386 is replaced by sending the first liquid mixed with the drug from the second reservoir to the third container without creating negative pressure in the first reservoir. .. In some embodiments, block 2386 is pharmaceutical without reducing the pressure in the first reservoir to less than 90% of atmospheric pressure, less than 80% of atmospheric pressure, or less than 70% of atmospheric pressure. The first liquid mixed with is sent from the second reservoir to the third container.

69-74 illustrate the syringe assembly 1402 and adapter assembly 1450 described above in the context of FIGS. 29-41. The steps, methods, advantages, and features described in the context of FIGS. 69-74 can be applied to any other syringe assembly, adapter assembly, and pressure regulating syringe system described herein. Some elements in FIGS. 69-74 are unnumbered to clarify specific elements. Many structures, steps, and / or methods exemplified and / or described in the context of other embodiments herein are the same or similar to those of the embodiments of FIGS. 69-74 (eg, adapter sets). Solid 1450s and barrel passages 1416), any structure, step, and / or method exemplified and / or described in other embodiments herein, in addition to or instead of those shown in FIGS. 69-74. Can be used. As shown in many of these figures, the syringe assembly 1402 and adapter assembly 1450 and container can be turned upside down to facilitate fluid transfer.

FIG. 69 illustrates cross-sectional views of the syringe assembly 1402, the adapter assembly 1450, and the first container 2400. For explanatory purposes, the syringe assembly 1402, the adapter assembly 1450, and the first container 2400 are not connected to each other in FIG. 69. In some embodiments, as illustrated, the system for transferring fluid into or out of a container comprises only two components, a syringe assembly 1402 and an adapter assembly 1450, and other additional or intervening. No adapter or connector is required. In some embodiments, the fluid connection between the syringe assembly and the adapter assembly 1450 can be achieved by industry standard connection methods. For example, the syringe may include a male luer for fluid transfer of ISO-594, and the adapter assembly 1450 may include a female luer receiver for fluid transfer of ISO-594. In some embodiments, the fluid connection between the syringe assembly and the adapter assembly 1450 is inappropriate, for example, when the type of therapeutic fluid in the syringe assembly is infused into the patient's fluid line and you want to prevent it. Etc. can be achieved by non-standard fluid connection methods.

The first container 2400 is configured to be mixed with a diluent, a reconstitution solution, a physiological saline solution, water, sterile water, a liquid drug, and / or a drug such as a powdered drug or a lyophilized drug. It can contain a liquid 2410, such as a liquid that is present. In some embodiments, the first container 2400 is a vial or bag containing a liquid. The first container 2400 may have a fixed volume or a variable volume.

Syringe assembly 1402 may include a number of different steps through which the syringe assembly 1402 may migrate in between or within. For example, the syringe assembly may be in a first stage, such as an initial stage. In some embodiments, in the first stage, the syringe assembly contains a gas (eg, sterile gas), but basically no liquid (almost or no). The syringe assembly can be in the second stage. The second step may be the step of filling the diluent. The syringe assembly may be in a third stage, such as draining the diluent. The syringe assembly can be in a fourth stage, such as the stage of filling the drug. The syringe assembly may be in a fifth stage, such as the stage of discharging the drug. Any of these steps can be omitted and / or other steps can be included. For example, one or more steps may be omitted and / or changed if the drug to be administered to the patient does not need to be diluted or mixed between these steps. In some embodiments, these steps can also be assigned different numbers and / or in different order.

In FIG. 69, the proximal plunger seal 1412 is located in the first stage. In the illustrated example, the peripheral portion 1406 (see FIG. 70) has a small volume (eg, essentially zero or near zero) that is too small to be seen in the example of FIG. As illustrated, the first reservoir 1420, the second reservoir 1444, and the peripheral portion 1406 are bounded on one or more sides by plunger seals 1412, 1428. In some embodiments (eg, without the proximal plunger seal 1412), the first reservoir 1420, the second reservoir 1444, and / or the peripheral portion 1406 are also constructed, formed, and formed in many other ways. / Or can be bordered. For example, reservoirs 1420, 1444 may be bounded by one or more bags, balloons, closed vessels, selectively accessible chambers, expanding or contracting chambers, and / or sliding chambers and the like.

The first reservoir 1420 may extend within the plunger between the proximal plunger seal 1412 and the distal plunger seal 1428. In some practices, the first reservoir 1420 contains a gas such as sterile gas or sterile air. In some embodiments, the proximal plunger seal 1412 is located distal to its most recent position during manufacture. This may provide room for expansion of the gas in the first reservoir 1420, such as during shipping. Proximal plunger seal 1412 is configured to slide within the internal channel while maintaining a seal on the inner wall of the internal channel of the plunger 1404. In some embodiments, the first reservoir 1420 of the first stage may include the volume of the internal channel from the distal end of the internal channel to the distal side of the proximal plunger seal 1412.

Figures 69-74 show, among other things, how the proximal plunger seal 1412 can slide to different positions within the internal channel of the plunger 1404. Proximal plunger seal 1412 can be sealed against the wall of the internal channel. For example, the proximal plunger seal 1412 can be sealed while sliding against the inner diameter of the inner wall of the plunger 1404. In some situations, the proximal plunger seal 1412 moves relative to the plunger 1404 and / or is substantially stationary relative to the barrel 1408. For example, this can occur when fluid is exchanged between the syringe assembly 1402 and a rigid container such as a glass vial. In some situations, the proximal plunger seal 1412 moves relative to barrel 1408 and / or is substantially stationary relative to plunger 1404. For example, this can occur during a fluid transfer operation when the syringe assembly 1402 is connected to a flexible container such as an IV bag. These situations are described in detail below.

In FIG. 69, the plunger 1404 is located in a first stage, such as its most distal position or the distal region of barrel 1408. In the illustrated example, the second reservoir 1444 (see FIG. 70) has a small volume (basically zero or nearly zero) that is too small to be seen in the example of FIG. 69, which is the distal plunger barrel. This is because the 1428 is in contact with the distal portion of the barrel 1408. The distal plunger seal 1428 may not be in contact with the distal portion of barrel 1408 in the first stage. The barrel 1408 may include an internal channel in which the plunger 1404 is configured to slide. In some embodiments, the second reservoir 1444 may include a distal portion of the internal channel of barrel 1408, distal to the distal plunger seal 1428 (see FIG. 70).

FIG. 70 illustrates a cross-sectional view of an adapter assembly 1450 coupled to a syringe assembly 1402 and to a first container 2400. For example, the first container may contain a diluent such as saline. The second reservoir 1444 can be part of the internal channel of barrel 1408 located between the distal plunger seal 1428 and the distal end of the internal channel.

In the second stage, the plunger 1404 is moved proximally, as indicated by the dashed arrow 2404. When the plunger 1404 is moved proximally, the distal plunger seal 1428 moves proximally, as indicated by the dashed arrow 2412. The volume of the second reservoir 1444 expands so that fluid (eg, liquid 2410) flows from the first container 2400 through the second passage of the adapter assembly 1450 into the second reservoir 1444, generally at the same time. , Proximal plunger seal 1412 moves distally, the volume of the first reservoir 1416 contracts and / or the volume of the peripheral portion 1406 expands, all of which occur automatically in some embodiments. , The user does not make any particular adjustments or movements. As illustrated, the device can be turned upside down to facilitate movement of the liquid 2410 into the second reservoir 1444.

When the first container 2400 has a fixed volume, when the fluid is taken out from the first container 2400, the pressure in the first container 2400 is reduced, and the gas arranged in the first reservoir 1420 is first. Adjust the pressure in the container 2400. The system sends gas from the first reservoir 1420 through the adapter assembly 1450 through the first passage into the first container 2400 to create a pressure difference between atmospheric pressure and the pressure in the first container 2400. Pressure can be adjusted until it decreases and / or disappears. When gas is sent from the first reservoir 1420 to the first container 2400, the proximal plunger seal can be moved distally, as indicated by the dashed arrow 2408. The volume of the first reservoir 1420 may decrease as the proximal plunger seal 1412 moves distally. In some embodiments, as illustrated, the first fluid reservoir 1420 and the second fluid reservoir 1444 are fluidly separated from each other and, at least by syringe 1402, do not communicate with each other. The contents of the reservoirs 1420, 1444 can communicate with each other via a container to which a syringe is attached.

In some embodiments, the system measures the pressure in the first container 2400 to be within about +/- 3% of atmospheric pressure, within about +/- 5% of atmospheric pressure, and about +/- 10 of atmospheric pressure. Pressure by sending gas from the first reservoir 1420 and / or to the first reservoir 1420 until within%, within about +/- 25% of atmospheric pressure, or within about +/- 50% of atmospheric pressure. Can be adjusted. In some embodiments, the system is used when the pressure in the vessel is greater than about 105% of atmospheric pressure, greater than about 115% of atmospheric pressure, greater than about 125% of atmospheric pressure, or greater. The pressure inside the vessel will be adjusted when it is greater than about 150% of the atmospheric pressure, and / or less than about 120% of the atmospheric pressure when the pressure inside the vessel is less than about 135% of the atmospheric pressure. When it is less than about 110% of the atmospheric pressure, or less than about 105% of the atmospheric pressure, the pressure adjustment is stopped. In some embodiments, the system is used when the pressure in the vessel is less than about 95% of the atmospheric pressure, less than about 85% of the atmospheric pressure, less than about 75% of the atmospheric pressure, or greater. When the pressure inside the container is less than about 50% of the atmospheric pressure, the pressure inside the container will be adjusted, and / or when the pressure inside the container is less than about 65% of the atmospheric pressure, it will be less than about 80% of the atmospheric pressure. When it is less than about 90% of the atmospheric pressure, or less than about 95% of the atmospheric pressure, the pressure adjustment is stopped. In some embodiments, the pressure threshold at which pressure adjustment is initiated is different from the pressure threshold at which pressure adjustment is stopped.

In some embodiments, the difference between the pressure in the vessel and the atmospheric pressure (eg, the pressure of ambient air) may be greater when the pressure adjustment is started than when the pressure adjustment is stopped. For example, a pressure difference of 3 pounds per square inch (“psi”) may be required for the pressure adjustment to begin, but a pressure difference of 1 psi may stop the pressure adjustment.

When the first container 2400 has a variable volume, the pressure in the first container 2400 does not necessarily decrease even if the fluid is taken out from the first container 2400. For example, the first container 2400 can be a compliant bag whose volume can be increased or decreased as needed to adjust the pressure in the first container 2400. Therefore, when the first container 2400 has a variable volume, even if the fluid is taken out from the first container 2400, the gas arranged in the first reservoir 1420 does not necessarily adjust the pressure in the first container 2400. .. As a result, the proximal plunger seal 1412 may not move and the volume of the first reservoir 1420 may not change. In some embodiments, one or more configurations and sequences of these steps may be different or omitted.

The adapter assembly 1450 may be mechanically and fluidly disconnected from the first container 2400 while the second reservoir 1444 contains the liquid. The adapter assembly 1450 then has to be mixed with the liquid drawn into the syringe assembly 1402 in the first step, such as concentrated liquid drugs, powdered drugs, lyophilized drugs, and / or lyophilized formulations. It can be connected to another container, such as a container containing a drug.

FIG. 71 illustrates a cross-sectional view of an adapter assembly 1450 coupled to a syringe assembly 1402 and to a second container 2450. As shown, the second container 2450A may contain a concentrated or reconstituted agent 2454, such as a concentrated liquid drug, powdered drug, lyophilized drug, and / or lyophilized formulation. In the third stage, the plunger 1404 is moved distally (as indicated by arrow 2458). This allows the distal plunger seal 1428 to be pushed distally (as indicated by arrow 2462) so that the liquid 2410 placed in the second reservoir 1444 is second via the adapter assembly 1450. It can be extruded (eg, sent or ejected) into a second container 2450 through a passage. This may facilitate the mixing of liquid 2410 with some or all of the concentrated or reconstituted drug 2454. The liquid 2410 sent or drained from the syringe assembly 1402 dilutes or reconstitutes the concentrated or reconstituted drug 2454 to the patient directly (eg, via a venous access port) or indirectly. It can be used to construct a medicinal solution that can be administered (eg, via an IV bag of saline connected to a patient). For example, the sent or discharged liquid 2410 may reconstitute the powdered drug or lyophilized formulation in the second container 2450, or dilute the concentrated drug in the second container 2450. In some embodiments, as the distal plunger seal 1428 moves distally, the volume of the second reservoir 1444 decreases or contracts, the volume of the first reservoir 1420 increases or expands, and / or the surrounding area. The 1406 reduces or contracts in volume, all at about the same time, all automatically, without any particular adjustment or movement by the user.

Some embodiments include injecting and / or delivering a liquid from the syringe assembly 1402 into a second container 2450. In some embodiments (the second container 2450 has a fixed volume), the syringe system 1402 and / or the adapter assembly 1450 has a second, for example, allowing gas (eg, air and / or steam) to escape. "Overpressure" can occur in the second container 2450 (because additional material is added to the second container 2450) unless the pressure in the container 2450 is adjusted. When the pressure in the second vessel rises above a certain threshold (eg, relative to atmospheric pressure), the gas from the second vessel 2450 passes through the first passage (via the adapter assembly 1450). It can flow through to the first reservoir 1420. The gas from the second container 2450 may contain vapors and / or fumes of harmful drugs. In some embodiments, the first reservoir 1420, syringe assembly 1402, adapter assembly 1450, and / or second container 2450 ensure that the gas from the second container 2450 does not mix with ambient air 244. It can form a closed system. The gas flowing into the first reservoir 1420 may cause the proximal plunger seal 1412 to move (eg, slide) relative to the plunger 1404 to increase the volume of the first reservoir 1420. This movement of the proximal plunger seal 1412 (indicated by arrow 2466) can reduce the volume of peripheral portion 1406 (which can be a third reservoir fluidized with ambient air via vent 1436). In some embodiments, the peripheral portion 1406 may be at least partially bordered by a vent 1436 and a plunger seal 1412. In some embodiments, the peripheral portion 1406 may be further bounded by the inner surface of the plunger 1404.

FIG. 72 illustrates a cross-sectional view of the adapter assembly 1450 removed from the syringe assembly 1402 after the syringe assembly 1402 has injected liquid into the second container 2450. The adapter assembly 1450 is connected to the second container 2450, but in some embodiments the adapter assembly 1450 is removed from the second container 2450.

As shown, the second container 2450 can be filled, at least in part, with a liquid formulation, a liquid drug, and / or a liquid drug 2470. The agent 2470 can be formed by combining the concentrated or reconstituted agent 2454 with the liquid 2410 sent or drained from the second reservoir 1444. In some embodiments, the second container 2450 is shaken, rocked, and / or agitated to facilitate diluting, reconstitution, and / or mixing the agent 2454 with liquid 2410. Including. The second vessel 2450 may be attached to or disconnected from the adapter assembly 1450 and / or the syringe assembly 1402 while shaking, rocking, stirring, reconstructing, and / or mixing. For example, as shown, the syringe assembly 1402 can be disconnected from the vial adapter 1450, thereby facilitating shaking of the vial adapter 1450 and the second container 2400.

In some embodiments, at or near the end of the third stage, each internal volume of the peripheral portion 1406 and / or the second reservoir 1444 is small (eg, essentially zero or near zero). Is. For example, in some embodiments, such as those illustrated in FIG. 72, one or both of these volumes are too small to be seen in FIG. 72 (hence not shown). Essentially all of the liquid in the second reservoir 1444 has already been transferred to the inner portion of the second container 1450 and the first reservoir 1420 is filled with gas (eg from the second container 2450). It was. In some embodiments, depending on the relative volume of the syringe assembly 1402 and the container 2450, one or both of the volumes of the peripheral portion 1406 and the second reservoir 1444 may be considerable even at the end of the third stage. obtain.

As shown in FIG. 73, the syringe assembly 1402 can communicate fluidly with the second container 2450. For example, if the syringe assembly 1402 is already disconnected from the vial adapter 1450 (see FIG. 72), it may be reconnected with the vial adapter 1450, as illustrated. Also, as shown, during the fourth step, the liquid formulation 2470 can be transferred (eg, harvested) from the second container 2450 to the second reservoir 1444 of the syringe assembly 1402. For example, in some variants, pulling the plunger 1404 proximally (as indicated by arrow 2480) or moving it otherwise causes the distal plunger seal 1428 to move proximally (as indicated by arrow 2484). (For example, sliding). Such movement of the distal plunger seal 1428 can increase the volume of the second reservoir 1444, thereby reducing the pressure in that space. This allows at least a portion of the liquid formulation 2470 in the second container 2450 (eg vial) to be drawn into the second reservoir 1444. In some practices, the liquid formulation 2470 comprises a liquid drug and / or a liquid drug. As illustrated, the device can be turned upside down to facilitate transfer of the liquid formulation 2470 into the second reservoir 1444.

In some practices, gas from the first reservoir 1420 may flow from the proximal first passage 1416 through a portion of the adapter assembly 1450 to the inner portion of the second container 2450. This can facilitate adjusting and / or roughly equalizing the internal pressure of the second container 2450 (eg, reducing the pressure difference between the atmospheric pressure and the gas in the second container 2450). In some embodiments, the volume of gas flowing from the first reservoir 1420 to the second container 2450 is proportional (eg, substantially equal) to the amount of volume change in the second reservoir 1444. In various embodiments, the volume of the first reservoir 1420 decreases as gas flows from the first reservoir 1420 to the second container 2450. This can reduce or substantially eliminate any pressure difference between the first reservoir 1420 and the surrounding atmospheric pressure. In some embodiments, the volume of the first reservoir 1420 is reduced by moving (eg, sliding) the distal plunger seal 1412 proximally (as indicated by arrow 2484). In some variants, the volume of the first reservoir 1420 is reduced by moving (eg, sliding) the proximal plunger seal 1412 distally to the plunger 1404 (as indicated by arrow 2488). In some embodiments, reducing the volume of the first reservoir may include reducing the volume of the bag in which the first reservoir is located.

As shown in FIG. 73, in some practices the plunger 1404 can be pulled proximally or otherwise moved. Thereby, the second reservoir 1444 may be able to expand and / or accommodate that volume to a volume approximately equal to the internal volume of the barrel 1408. In some practices, the plunger 1404 is proximal until the distal plunger seal 1428 is near or near the proximal end of the barrel 1408 and / or near or abuts the proximal plunger seal 1412. Moved to. Thus the maximum volume of the second reservoir 1444 can be obtained. In one variant, the proximal plunger seal 1412 is relative to barrel 1408 when the fluid is transferred between the second container 2450 (eg, a container of generally constant volume) and the second reservoir 1444. Remains virtually stationary.

In various embodiments, the syringe assembly 1402 can be disconnected from the adapter assembly 1450 and / or the second container 2450. In some embodiments, the syringe assembly 1402 may be coupled to a medical connector such as the connector 2200 shown in FIGS. 62-65. The connector 2200 may be connected to a container such as a bag (eg, the IV bag 2250 shown in FIG. 66), a port, or other place to access medical fluids. In some variants, the vessel is flexible or elastic, has a variable volume, and / or is not a rigid vessel. In some practices, the pressure inside and / or outside the vessel is approximately ambient pressure (or atmospheric pressure). In some embodiments, the container can expand and contract as fluid is added to and drawn from the container. In certain embodiments, the medical connector or container communicates fluid with the patient's blood flow.

In various practices, in the fifth step, the syringe assembly 1402 may transfer some or substantially all of the fluid (eg, liquid formulation 2470) in the second reservoir 1444 to the container. In some variants, the plunger 1404 is moved distally, whereby the distal plunger seal 1428 can also be moved distally. This reduces the volume of the second reservoir 1444, which can increase its internal pressure. This may facilitate the fluid from the second reservoir 1444 (eg, liquid formulation 2470) into the container through the connector 2200.

If the connector 2220 is connected to a container with rigid and / or constant pressure (eg, a glass vial), the flow of fluid from the second reservoir 1444 can tend to increase the pressure in the container. This is because the volume of the rigid container has not changed even though the liquid flowing into the container has added a substance to the contents of the rigid container. As mentioned above, some embodiments reduce such pressure increases by allowing a portion of the contents of the vessel (eg, a conditioning fluid such as a gas) to flow from the vessel into the first reservoir 1420. Or configured to avoid it. In some embodiments, the pressure of the rigid vessel can be substantially invariant, as such transfer of the conditioning fluid substantially offsets the amount of liquid added to the vessel.

In various embodiments, injecting fluid into and from the syringe assembly (inflow of conditioning gas into the first reservoir or outflow of conditioning gas from the first reservoir and liquid from the second reservoir). The outflow or influx of liquid into the second reservoir) keeps the volumes of the first and second reservoirs substantially equal. In some embodiments, this transfer of fluid keeps the pressure in the reservoir substantially equal. For example, the pressure can be maintained substantially as ambient pressure. This can reduce or avoid the pressure gradient between the perimeter and the first reservoir during the fluid transfer operation. Therefore, if the plunger 1404 is moved relative to the barrel 1408 during the fluid transfer operation between the syringe assembly 1404 and the rigid vessel 2400, the proximal plunger seal 1412 slides within the plunger 1404 (eg, plunger 1404). Can move relative to) and / or be substantially stationary relative to barrel 1408.

A second, if the connector 2220 is connected to a flexible or elastic container (eg, a container with an inconsistent volume, such as an IV bag), or a medical connector that communicates with the patient's blood flow. The fluid flow from the reservoir 1444 may tend not to significantly affect the pressure in the vessel, at least until the vessel reaches the expansion limit. This is because the volume of blood flow in the container or patient can change as fluid is added or removed. In some practices, when liquid is applied to the flexible vessel from the second reservoir 1444, the flexible vessel expands by an amount that substantially offsets this addition, thereby substantially reducing the pressure in the vessel. Can be kept unchanged. In some practices, the total volume of the second reservoir 1444 and the flexible vessel is approximately constant.

As mentioned above (eg, with respect to FIGS. 69-73), in one or more of the previous steps, the liquid formulation 2470 may be loaded into the second reservoir 1444. In some embodiments, during such loading, the plunger 1404 is operated until the distal plunger seal 1428 is at or near the proximal end or region of barrel 1408 and / or the proximal plunger seal 1412. It is moved proximally until it comes close or touches. When the syringe assembly 1402 is connected to the connector 2220 and the connector 2200 is connected to a variable volume container (eg IV bag), the plunger 1404 can be pushed distally in the fifth step. The fifth step may also be performed to transfer the liquid from the second reservoir into a container with a fixed or substantially fixed volume. Liquid transfer during the fifth stage also moves the distal plunger seal 1428 distally, thereby facilitating the flow of liquid formulation 2470 from the second reservoir 1444 through the connector 2200 into the flexible container. Can be done. In some embodiments, the distal movement of the plunger 1404 and / or the distal plunger seal 1428 tends to increase the volume of the first reservoir 1420. This can reduce the pressure in the first reservoir 1420 at about the same time and without any particular adjustment or movement by the user.

In some examples, the pressure drop in the first reservoir 1420 is largely offset by transferring a corresponding amount of conditioning fluid from the vessel to the first reservoir 1420. However, in some cases, the flexible container may not contain (or not contain) a sufficient amount of conditioning fluid (eg, air or other gas). For example, some IV bags are formed by laminating substantially flat multilayer sheets along the periphery, but such IV bags have little or no internal volume in the initial empty flat state. (Basically, there is no gas in the IV bag, or there is less gas than the amount of liquid to be added to the IV bag). The IV bag may be configured to expand its internal volume in later states. In some configurations, the orientation of the syringe assembly 1402 and the flexible vessel may prevent or prevent the conditioning fluid from being transferred to the first reservoir 1420. For example, in an orientation in which the syringe assembly 1402 is approximately upside down and / or placed below the container, the gas in the container (which can act as a conditioning fluid) rises towards the top of the container and thus the syringe. It can be separated from the assembly 1402.

In one embodiment, the syringe assembly 1402 is pressed and / or liquid is pressed against the plunger 1404 with no or substantially no adjustment fluid transferred from the flexible vessel to the first reservoir 1420. It may be configured to allow transfer from a second reservoir 1444 to a flexible container. This can reduce the possibility of forming a pressure difference (eg, between the first reservoir 1420 and the second reservoir 1444 and / or between one or both of the reservoirs 1420, 1444 and the ambient environment). Such a pressure difference may prevent the user from further pressing the plunger and / or transferring the liquid into the flexible container. With such a pressure difference, a proximal force can be generated against the plunger as the liquid in the second reservoir 1444 is drained. This may require the user to stop the plunger so that the freshly drained liquid is not sucked back into the second reservoir 1444 or requires an ambient air inlet leading to the first reservoir 1420. In the latter case, ambient contaminants can enter the system and / or cause harmful liquids or vapors to leak from the system to the surroundings.

In certain embodiments, as illustrated, the total volume of the first reservoir 1420 and the second reservoir 1444 combined is variable and does not need to be constant during use. This may facilitate maintaining approximately equal pressures in the first reservoir 1420 and the second reservoir 1444 without the need for a flow of conditioning fluid in the vessel. In some embodiments, moving the plunger 1404 distally reduces the volume of the second reservoir 1444. As detailed below, in some embodiments, the volume of the first reservoir 1420 remains substantially constant as the syringe assembly 1402 transfers the fluid into the flexible container. possible. Therefore, the total volume of the first reservoir 1420 and the second reservoir 1444 can change (eg decrease). In various embodiments, the volume of the first reservoir 1420 varies as a function of the amount of longitudinal movement of the proximal plunger seal 1412 relative to the plunger 1404. This change can be linear, exponential, or other.

As described above, the first reservoir 1420 may be configured to have a generally constant volume at one or more stages, such as when the conditioning fluid is not transferred to the first reservoir 1420. In certain embodiments, the proximal plunger seal 1412 and the distal plunger seal 1428 are the proximal and distal ends of the first reservoir 1420, respectively. The volume of the first reservoir 1420 when the plunger 1404 and the distal plunger seal 1428 move distally, but the proximal plunger seal 1412 remains nearly stationary (at least relative to the barrel 1408 of the syringe). Will increase. In such a case, if the conditioning fluid is not transferred to the first reservoir 1420, the pressure in the first reservoir 1420 will drop. This pressure gradient allows the proximal plunger seal 1412 to move distally due to atmospheric pressure acting on its outer surface (eg, via vent 1436).

In one embodiment, the proximal plunger seal 1412 travels a distal distance sufficient to offset the distal movement of the distal plunger seal 1428. In some variants, the proximal plunger seal 1412 travels a distance sufficient to keep the volume of the first reservoir 1420 nearly constant, while the volumes of the first reservoir 1420 and the second reservoir 1444. The total volume is reduced (because the volume of the second reservoir 1444 is reduced). In various embodiments, the proximal plunger seal 1412 is relative to barrel 1408 when the syringe assembly 1404 is connected to the flexible vessel 2400 and the plunger 1404 moves relative to barrel 1408. It is moving and / or substantially stationary relative to the plunger 1404. In some practices, the proximal plunger seal 1412 moves relative to both barrel 1408 and plunger 1404.

Typically, the first reservoir 1420, the second reservoir 1444, the inside of a flexible container (eg IV bag), and / or the ambient environment do not require ambient air to be introduced into the first reservoir 1420. / Or the ambient air and the first reservoir 1420 do not need to be fluid-communicated, and are at about atmospheric pressure or at about the same pressure, respectively. In some embodiments, moving the plunger 1404 distally transfers liquid from the second reservoir 1444 to the flexible container, which expands and thereby in the second reservoir 1444. And the inside of the flexible container is maintained at about atmospheric pressure. In some embodiments, when the plunger 1404 is moved distally, the pressure of the ambient environment also moves the proximal plunger seal 1412 distally, thereby maintaining approximately atmospheric pressure within the first reservoir 1420. However, the first reservoir 1420 is sealed from the ambient air.

In various embodiments, the proximal plunger seal 1412 moves approximately in series with the plunger 1404 approximately simultaneously while transferring the liquid from the second reservoir 1444 into the flexible container. For example, the position of the proximal plunger seal 1412 with respect to the plunger 1404 and / or the distal plunger seal 1428 can be substantially constant during such liquid transfer.

FIG. 74 shows that the plunger 1404 has moved proximally to a substantially most recent position (thus transferring fluid to a second reservoir 1444) and then to a substantially distal position. After moving distally to, thereby injecting fluid from the second reservoir 1444 through the connector 2200 into a flexible container (not shown) or a medical connector that communicates with the patient's bloodstream. An embodiment of the syringe assembly 1402 is illustrated. As mentioned above, such transfer can expand the flexible container. As shown, during the distal movement of the plunger 1404, the proximal plunger seal 1412 is moving with the plunger 1404 (eg, it remains substantially stationary relative to the plunger 1404). In some embodiments, this allows the volume of the first reservoir 1420 to remain largely constant. In various practices, the proximal side of the proximal plunger seal 1412 is in fluid communication with ambient air, for example via vent 1436.

In various embodiments, when the second reservoir 1444 is at or near the minimum volume, the volume of the first reservoir 1420 is at least about 0.5 ml and / or about 100 ml or less, at least about 1. It can be milliliters and / or about 20 milliliters or less, or at least about 3 milliliters and / or about 10 milliliters or less. In some embodiments, when the second reservoir 1444 reaches a minimum volume, the volume of the first reservoir 1420 is at least about 2% of the maximum volume of the second reservoir 1444 and / or the second reservoir 1444. It can be less than or equal to about 50% of the maximum volume of. In some embodiments, when the second reservoir 1444 reaches a minimum volume, the volume of the first reservoir 1420 is at least about 5% of the maximum volume of the second reservoir 1444 and / or the second reservoir 1444. It can be less than or equal to about 20% of the maximum volume of. In the embodiment in which the first reservoir 1420 and the second reservoir 1444 have volume independence, the volume of the first reservoir 1420 does not necessarily change even if the volume of the second reservoir 1444 changes, but both reservoirs are fixed. In the case of fluid connection via a volumetric container, the volume of the first reservoir 1420 may change as the volume of the second reservoir 1444 changes.

75A-75C illustrate side sectional views of the syringe assembly 1402 drawing fluid from the second container 2450. In FIG. 75A, the distal plunger seal 1428 is in the most distal position. As a result, the second reservoir 1444 can have a minimum volume (eg, substantially no volume). Proximal plunger seal 1412 is in the most recent position, also as shown in FIG. 75A. In some embodiments, the first reservoir 1420 has the maximum volume when the distal plunger seal 1428 is in the most distal position and the proximal plunger seal 1412 is in the most recent position. In one practice, as the plunger 1404 moves proximally relative to barrel 1408, the withdrawal fluid (eg, liquid formulation 2470) can be withdrawn from the second container 2450 (eg, withdrawn, withdrawn, or so). Can be harvested instead). For example, fluid can travel from the adapter assembly 1450 (as shown in FIG. 75B) through the proximal second passage 1424 and / or into the second reservoir 1444. In some embodiments, the position of the proximal plunger seal 1412 with respect to barrel 1408 remains largely constant (eg, substantially non-moving) while the plunger 1404 is moving proximally. In some embodiments, the position of the distal plunger seal 1428 with respect to the vent 1436 remains largely constant (eg, substantially non-moving) while the plunger 1404 is moving proximally. To facilitate transfer of the liquid formulation 2470 to the second reservoir 1444, the syringe assembly 1402, adapter assembly 1450, and second container 2450 can be turned upside down together, as shown in FIG. 75B. ..

In some variants, when the liquid formulation 2470 is withdrawn from the second container 2450, the conditioning fluid 1596 (eg gas) from the first reservoir 1420 flows into the second container 2450 (eg refills). ) The pressure in the second container 2450 can be adjusted. In some embodiments, the conditioning fluid 1596 flows through the liquid formulation 2470 in the second container 2450, such as when the device is turned upside down, as shown in FIG. 75B. The first reservoir 1420 has a volume smaller than that of FIG. 75A in FIG. 75B due to the fluid 1596 flowing from the first reservoir 1420 into the second container 2450.

In FIG. 75C, substantially all (eg, at least about 90%) of the liquid formulation 2470 has been transferred from the second container 2450 to the second reservoir 1444 and / or the second reservoir 1444 is the liquid formulation 2470. Is substantially filled (for example, up to at least 90% capacity). In some embodiments, the second container 2450 is filled with fluid 1596 from the first reservoir 1420.

In FIG. 75C, the distal plunger seal 1428 is in the most recent position and the proximal plunger seal 1412 is in the most distal position. In some embodiments, the proximal plunger seal 1412 is moved distally (eg, relative to the second vessel 2450 and relative to the plunger 1404), and the first fluid (eg, relative to the plunger 1404). Displace the distal plunger seal (eg into the second container 2450) while removing the liquid formulation (2470) from the second container 2450 and / or injecting the second fluid (eg fluid 1596) into the second container 2450. Includes moving proximally (relative to). In some embodiments, the proximal plunger seal 1412 is moved proximally relative to the plunger 1404 (eg, transferring gas from the second vessel 2450 into the syringe assembly 1402) and fluid. Moving the distal plunger seal 1428 distally (eg relative to the second container 2450) while injecting (eg water, physiological saline, liquid formulation 2470) into the second container 2450. including.

The order in which the flow control unit can be opened and closed in some embodiments is described above in the context of FIGS. 46 and 47. The flow control unit includes means for opening and closing passages such as the first passage and the second passage described in the context of various embodiments. In some embodiments, the flow control unit can be opened and / or closed in any possible order. Some embodiments include a flow control unit that is configured to open and close in a particular order. The shapes of the various components can be configured such that one flow control unit opens and / or closes before another flow control unit. The flow control unit may include valves and / or seals that are configured to block, seal, and / or prevent flow in the aisle when the flow control unit is in the closed position. The flow control unit may include valves and / or seals that are configured to allow and / or allow flow in the aisle when the flow control unit is in the open position.

76A and 76B illustrate a schematic diagram of the fluid transfer assembly 2500 and the adapter assembly 2504 connected to the container assembly 2508. In FIG. 76A, the fluid transfer assembly 2500 is not connected to the adapter assembly 2504, but the adapter assembly 2504 is connected to the container assembly 2508. In FIG. 76B, the adapter assembly 2504 is connected to the fluid transfer assembly 2500 and the container assembly 2508.

The fluid transfer assembly 2500 may include a first reservoir 2512 and a second reservoir 2516. The first reservoir 2512 may include a first passage 2520. The first flow control unit 2524 may be configured to open and close the first passage 2520. The second reservoir 2516 may include a second passage 2528. A second flow control unit 2532 may be configured to open and close the second passage 2528.

The adapter assembly 2504 may include a third passage 2540. A third flow control unit 2544 may be configured to open and close the third passage 2540. The adapter assembly 2504 may include a fourth passage 2548. A fourth flow control unit 2552 may be configured to open and close the fourth passage 2548.

Next, referring to FIG. 76B, the first passage 2520 may be fluidly and / or mechanically connected to the third passage 2540. In some embodiments, when the first passage 2520 is mechanically connected to the third passage 2540, the first flow control unit 2524 and the third flow control unit 2544 are in open positions to allow fluid to flow. The first passage 2520 is automatically fluid connected to the third passage 2540 by allowing it to flow between the first reservoir 2512 and the inner portion of the container assembly 2508.

In some embodiments, in order to allow the container assembly 2508 to fluidly communicate with the first reservoir 2512 through the first passage 2520 and the third passage 2540, a first flow control unit 2524 and a third Both of the flow control units 2544 need to be in the open position (eg, fluid feed position). In some embodiments, when the fluid transfer assembly 2500 (eg, syringe assembly) is mechanically coupled to the adapter assembly 2504, the first flow control unit 2524 is before the third flow control unit 2544 opens. Will open automatically. In some embodiments, when the fluid transfer assembly 2500 (eg, syringe assembly) is mechanically coupled to the adapter assembly 2504, the third flow control unit 2544 is before the first flow control unit 2524 opens. Will open automatically.

In the context of FIGS. 76A and 76B, "automatically open" is due to and / or as a result of the act of mechanically connecting the fluid transfer assembly 2500 to the adapter assembly 2504, the flow control unit. Means to open. Many other embodiments described herein are configured to open automatically. In some embodiments, when the syringe assembly is mechanically connected to the adapter assembly or connector via threads, at least one, some, or all flow controls are automatically opened. For example, the syringe assembly can be screwed over and / or inside the adapter assembly or connector.

In some embodiments, when the fluid transfer assembly 2500 (eg, syringe assembly) is mechanically disconnected from the adapter assembly 2504, the first flow control unit 2524 may be replaced by a third flow control unit 2544. Automatically closes before closing. In some embodiments, when the fluid transfer assembly 2500 (eg, syringe assembly) is mechanically disconnected from the adapter assembly 2504, the third flow control unit 2544 will be combined with the first flow control unit 2524. Automatically closes before closing. In the context of FIGS. 76A and 76B, "automatically closing" means that the flow control unit closes due to the act of mechanically disconnecting the fluid transfer assembly 2500 from the adapter assembly 2504. .. Many other embodiments described herein are configured to close automatically.

The second passage 2528 may be fluidly and / or mechanically connected to the fourth passage 2548. In some embodiments, when the second passage 2528 is mechanically connected to the fourth passage 2548, the second flow control unit 2532 and the fourth flow control unit 2552 are in open positions to allow fluid to flow. The second passage 2528 is automatically fluid connected to the fourth passage 2548 by allowing it to flow between the second reservoir 2516 and the inner portion of the container assembly 2508.

In some embodiments, in order to allow the container assembly 2508 to fluidly communicate with the second reservoir 2516 via the second passage 2528 and the fourth passage 2548, a second flow control unit 2532 and a fourth Both flow control units 2552 need to be in open positions (eg, fluid feed positions). In some embodiments, when the fluid transfer assembly 2500 (eg, syringe assembly) is mechanically coupled to the adapter assembly 2504, the second flow control unit 2532 is before the fourth flow control unit 2552 opens. Will open automatically. In some embodiments, when the fluid transfer assembly 2500 (eg, syringe assembly) is mechanically coupled to the adapter assembly 2504, the fourth flow control unit 2552 is before the second flow control unit 2532 opens. Will open automatically.

In some embodiments, when the fluid transfer assembly 2500 (eg, syringe assembly) is mechanically disconnected from the adapter assembly 2504, the second flow control unit 2532 is combined with the fourth flow control unit 2552. Automatically closes before closing. In some embodiments, when the fluid transfer assembly 2500 (eg, syringe assembly) is mechanically disconnected from the adapter assembly 2504, the fourth flow control unit 2552 becomes a second flow control unit 2532. Automatically closes before closing.

In some embodiments, the flow control unit is a third flow control unit 2544, a first flow control unit 2524, a second flow when the fluid transfer assembly 2500 is mechanically coupled to the adapter assembly 2504. The control unit 2532 and the fourth flow control unit 2552 are opened in this order (for example, opened). In some embodiments, the order is a first flow control unit 2524, a third flow control unit 2544, a second flow control unit 2532, and a fourth flow control unit 2552. In some embodiments, the order is a third flow control unit 2544, a first flow control unit 2524, a fourth flow control unit 2552, and a second flow control unit 2532. All other orders are also contemplated by this disclosure.

In some embodiments, when the fluid transfer assembly 2500 is mechanically coupled to the adapter assembly 2504, the passage to the liquid reservoir opens (eg, opens) before the passage to the gas reservoir opens (eg, opens). To do). In some embodiments, when the fluid transfer assembly 2500 is mechanically coupled to the adapter assembly 2504, the passage seal 2560 closes (eg seals) before the passage to the liquid reservoir opens (eg opens). ). In some embodiments, this method reduces the likelihood of fluid in the syringe assembly and / or vessel leaking into the ambient air (eg, due to the pressure gradient between the syringe assembly and the vessel). it can.

Some embodiments include a flow control unit that seals all passages from ambient air (eg, even if one of the passages otherwise leaks into the ambient air). This flow control unit is shown as a passage seal 2560 in FIG. 76B, as a distal seal 1264 in FIG. 77, as a first seal in FIG. 51, and as a first seal 1470 in FIG. In some embodiments, the flow control unit (eg, passage seal 2560 in FIG. 76B, distal seal 1264 in FIG. 77, first seal in FIG. 51, and first seal 1470 in FIG. 41) is a third. Flow control unit 2544, first flow control unit 2524, second flow control unit 2532, and / or fourth flow control unit 2552 fluidly isolates the passage joining area 2570 before opening. The passage junction area 2570 is the area between the fluid transfer assembly 2500 (eg, syringe assembly) and the adapter assembly 2504, where the first passage 2520 is connected to the third passage 2540 and the second passage 2540. The passage 2528 is connected to the fourth passage 2548. In some embodiments, the passage seal 2560 is provided after the third flow control unit 2544, the first flow control unit 2524, the second flow control unit 2532, and / or the fourth flow control unit 2552 are closed. At, the fluid isolation of the passage junction area 2570 is stopped. In other words, in some embodiments, the passage seal 2560 has a third flow control unit 2544, a first flow control unit 2524, a second flow control unit 2532, and / or a fourth flow control unit 2552. After the closed position, the open position is reached.

In some embodiments, the passage seal 2560 is in the closed (eg, sealed) position while the fluid transfer assembly 2500 is mechanically connected to the adapter assembly 2504, while the first flow control unit. The 2524, the third flow control unit 2544, the second flow control unit 2532, and the fourth flow control unit 2552 are in the open (for example, opened) position, and the first passage 2520 is combined with the third passage 2540 and the fluid. The second passage 2528 is fluidly communicated with the fourth passage 2548, while the first passage 2520 and the third passage 2540 are sealed from the second passage 2528 and the fourth passage 2548. ing.

When the fluid transfer assembly 2500 is mechanically disconnected from the adapter assembly 2504, the first flow control unit 2524 may include a third flow control unit 2544, a second flow control unit 2532, and / or a second. Before the flow control unit 2552 of 4 is in the closed position (for example, while the third flow control unit 2544, the second flow control unit 2532, and / or the fourth flow control unit 2552 are in the open position). It can be in a closed (eg, sealed) position.

In some embodiments, the flow control unit is a first flow control unit 2524, a third flow control unit 2544, a first flow control unit 2524, when the fluid transfer assembly 2500 is mechanically disconnected from the adapter assembly 2504. The flow control unit 2552 of 4 and the second flow control unit 2532 are closed (for example, sealed) in this order. In some embodiments, the flow control unit is a first flow control unit 2524, a fourth flow control unit 2552, a first flow control unit 2524, when the fluid transfer assembly 2500 is mechanically disconnected from the adapter assembly 2504. The flow control unit 2544 of 3 and the second flow control unit 2532 are closed (for example, sealed) in this order. All other orders are also contemplated by this disclosure.

In some embodiments, when the fluid transfer assembly 2500 is mechanically disconnected from the adapter assembly 2504, the passage to the gas reservoir is before the passage to the liquid reservoir is closed (eg, sealed). Close (eg seal). In some embodiments, when the fluid transfer assembly 2500 is mechanically disconnected from the adapter assembly 2504, the passage to the gas reservoir is closed (eg, for example) before the passage seal 2560 is opened (eg, opened). Seal) and close the passage to the liquid reservoir (eg seal).

FIG. 77 illustrates another embodiment of the pressure regulating syringe system 1200, similar to the embodiments illustrated in FIGS. 76A and 76B. The passage seal 2560 of FIG. 76B includes the distal seal 1264 of FIG. 77. The first flow control unit 2524 controls the flow in the proximal first passage 1224. The second flow control unit 2532 controls the flow in the proximal second passage 1250. The third flow control unit 2544 controls the flow in the distal first passage 1246. The fourth flow control unit 2552 controls the flow in the distal second passage 1254. In the embodiment illustrated in FIG. 77, the fluid communication between the first reservoir 308 and the vessel assembly 2508 is a flow control unit (eg 2524) associated with the passage between the first reservoir 308 and the vessel assembly 2508. , 2544) can occur when in the open (eg, open) position. In the embodiment illustrated in FIG. 77, the fluid communication between the second reservoir 312 and the vessel assembly 2508 is a flow control unit (eg 2532) associated with the passage between the second reservoir 312 and the vessel assembly 2508. , 2552) can occur when in the open (eg open) position.

Returning to FIGS. 38 and 39, the proximal first passage 1416 may be sealed, obstructed, and / or closed by the movement of the third seal 1562. For example, the third seal 1562 can be moved distally so that the third seal 1562 seals against the inner surface 1580 (as shown in FIG. 38). Proximal first passage 1416 is a third seal 1562 with the syringe assembly 1402 connected to the adapter such that the adapter engages (eg, pushes) the distal portion 1584 of the passage shaft 1574 in the proximal direction. Can be opened, opened, and / or opened as it moves from the sealed, obstructed, and / or closed position to the opened, opened, and / or open position. Therefore, the third seal 1562 and the inner surface 1580 may form the first flow control unit 2524 in FIGS. 76A, 76B, and 77.

38 and 39 also show that the proximal second passage 1424 is alternately sealed, obstructed, and / or closed (see FIG. 38), opened, opened, and / or opened (see FIG. 39). ) Shows to get. The distal portion 1584 of the passage shaft 1574 may include a tapered portion that seals, interferes, and / or closes with respect to the tapered portion 1548 of the distal cap 1550 in the sealing zone 1590. Therefore, the sealing zone 1590 of FIG. 38 may form a second flow control unit 2532 in FIGS. 76A, 76B, and 77.

Further returning to FIG. 36A, the distal first passage 1246 has a radial protrusion 1508 such that the radial protrusion 1508 of the second seal 1486 does not contact the medial tapered region 1518 of the adapter assembly 1450. Can be opened, opened, and / or opened by moving the. Therefore, the radial protrusions 1508 and the medially tapered region 1518 can form a third flow control unit 2544 in FIGS. 76A, 76B, and 77.

FIG. 36A illustrates a distal second passage 1254 in the open, open, and / or open position, where the second seal 1486 is distal (rather than the proximal seal position 1502). Because in position, the second seal 1486 does not cover, seal, block, and / or interfere with the radial hole 1528. As a result, fluids (such as medical fluids) can flow through the distal second passage 1254 and through the radial hole 1528 into the proximal second passage 1424 (shown in FIG. 39). Therefore, the second seal 1486 and the radial hole 1528 may form a fourth flow control unit 2552 in FIGS. 76A, 76B, and 77.

In some embodiments, the adapter 1208 is attached directly to the syringe assembly 1204 without the need for intermediate components to connect the adapter 1208 to the syringe assembly 1204. In some embodiments, the adapter 1208 is attached directly to the container (eg, container assembly 2508) without the need for intermediate components to connect the adapter 1208 to the container. By mounting directly, the number of components and / or assemblies required to use the syringe assembly 1204 and / or the adapter assembly 1208 can be reduced. Then referring to FIGS. 41 and 65, the syringe assembly 1402 can be directly connected (eg, attachable) to the adapter assembly 1450 and can be directly connected (eg, attachable) to the connector 2200. Thus, the syringe assembly 1402 is compatible with both the adapter assembly 1450 (eg vial adapter) and the connector 2200 (eg connector configured to connect the syringe assembly 1402 to a tube or bag).

FIG. 78 shows the syringe assembly in a first embodiment, such as before the syringe assembly 1402 is connected to the adapter assembly 1450 (attached to the container 2700) or after the syringe assembly 1402 and the adapter 1450 are disconnected. A cross-sectional view of the distal portion of solid 1402 is illustrated. The first seal 1470 is in the open position (eg, because it does not contact a portion of the syringe assembly 1402 to seal the passage junction area). The second seal 1486 is in a closed position that seals the distal first passage 1246 and the distal second passage 1254. The third seal 1562 is in a closed position that seals the proximal first passage 1416. The sealing zone 1590 is in a closed position to seal the proximal second passage 1424.

FIG. 79 shows a second connection, such as during coupling (eg, just before the syringe assembly 1402 is fully connected to the adapter assembly 1450) or during disconnection (eg, when the syringe assembly 1402 begins to separate from the adapter assembly 1450). The cross-sectional view of the distal portion of the syringe assembly 1402 in the form of is illustrated. The third seal 1562 is about to seal against the inner wall, and the third seal 1562 seals the proximal first passage 1416. As a result, the first reservoir (not shown) does not have fluid communication with the container 2700, even if the distal first passage 1246 is in the open (eg, open) position. The proximal second passage 1424 and the distal second passage 1254 are in open (eg, opened) positions. As a result, the second reservoir (not shown) is still in fluid communication with the container 2700.

Although various pressure regulation systems have been disclosed in the context of specific embodiments and examples, the pressure regulation systems of the present disclosure go beyond the specifically disclosed embodiments to other alternative embodiments and / or embodiments. The use of forms and specific modifications and their equivalents are extended. For example, some embodiments are configured to use a conditioning fluid that is a liquid (such as water or saline) rather than a gas. As another example, in some embodiments, the bag comprises a bellows. As another example, in some embodiments, various components are integrated and / or replaced by a single component. The various features and aspects of the disclosed embodiments can be combined or replaced with each other to form different forms of pressure regulation systems. Therefore, the scope of the pressure regulation system of the present disclosure is not limited by the particular embodiments described above and should only be determined by reading the current and / or future claims correctly.

The particular features described in this disclosure in the context of separate implementations can also be implemented in combination in a single implementation. Conversely, the various features described in the context of a single implementation can also be implemented separately in multiple implementations or in any suitable subcombination. Further, although each feature may have been described above as acting in a particular combination, one or more features of the claimed combination may optionally be implemented from that combination, which combination is any subcombination. Can be claimed as, or as a variant of any subcombination.

All steps, processes, structures, and / or devices disclosed or illustrated in one embodiment, flowchart, or example of the present disclosure, all steps disclosed or exemplified in another embodiment, flowchart, or example. , Process, structure, and / or can be used in combination with or with (or instead of) any other part of the device. The embodiments and examples described herein are distinct and inseparable from each other. Combinations, variants, and other practices of the disclosed features are within the scope of this disclosure.

Any step or block can be adjusted or modified. Other or additional steps may also be used. None of the steps or blocks described herein are mandatory or essential. Further, although each operation may be illustrated or described herein in a particular order, such operations need not be performed in the specific order or sequence shown to obtain the desired result. It is not necessary to perform all of the operations. Other actions not shown or described may be incorporated into the methods and processes as an example. For example, one or more additional actions can be performed before, after, at the same time, or in between any of the described actions. In addition, the actions may be reconfigured or reordered in other practices. Also, the separation of the various system components in the above implementation should not be understood that such separation is required in every practice, and the described components and systems are generally integrated as a single product. It should be understood that it can be made or packaged as multiple products.
As used herein, terms related to circular shapes such as diameter or radius do not require a perfect circular structure and shall apply to any suitable structure with a cross-sectional area that can be measured laterally. Shape-related terms such as "circular" or "cylindrical" or "semi-circular" or "semi-cylindrical", or any related or similar term, are the mathematics of circles, cylinders and other structures. It does not have to be strictly in line with the definition and can include structures of reasonable approximation. Similarly, a shape modified by the word "generally" (eg, "generally cylindrical") may include a reasonable approximation of that shape.

Conditional (hypothetical) terms used herein, such as "can," "get," "may," "may," and "for example," are used unless otherwise noted. Unless otherwise understood in one context, the embodiment shall generally mean that, unlike other embodiments, it comprises a particular feature, element, and / or step. .. Thus, such conditional (hypothetical) terms generally require some features, elements, and / or steps for one or more embodiments, or one or more embodiments. , Any particular embodiment must include logic to determine (with or without the author's opinion or instructions) whether or should these features, elements, and / or steps be included or should be implemented. It doesn't mean that you have to.

Concatenated terms such as the phrase "at least one of X, Y, and Z" generally mean that the article, term, etc. may be any of X, Y, or Z, unless otherwise noted. Understood in the context of typical usage. Therefore, in general, such a connecting phrase requires that a particular embodiment be present at least one of X, at least one of Y, and at least one of Z, respectively. It does not mean that.

Terms such as "prepare," "include," and "have" are synonymous and are used comprehensively, open-ended, and do not exclude additional elements, features, actions, actions, and the like. Also, the term "or (or)" is used in a comprehensive sense (and therefore not in an exclusive sense), so for example, the term "or (or)" is used to connect a list of elements. When, it means one, some, or all of the list.

The term "and (and) / or (or)" means that "and (and)" applies to some embodiments and "or (or)" applies to some embodiments. .. Thus, A, B, and / or C can be rewritten as A, B, and C in one sentence and A, B, or C in another. With A, B, and / or C, some embodiments may include A and B, some embodiments may include A and C, and some embodiments may include B and C. It may include, some embodiments may contain only A, some embodiments may contain only B, some embodiments may contain only C, and some embodiments may contain A, B and C. Means that it can include. The terms "and / or" are used to avoid unnecessary duplication.

As used herein, the terms "approximately," "about," and "substantially" refer to an amount close to the stated amount that still performs the desired function or achieves the desired result. For example, in some embodiments, as the context suggests, the terms "approximately," "about," and "substantially" can refer to quantities within 10% of the amount described. As used herein, the term "generally (almost)" refers to a value, quantity, or feature that primarily comprises or tends to include or tend to a particular value, quantity, or feature. As an example, in some embodiments, as the context suggests, the term "generally parallel" can refer to something deviating from the state of being strictly parallel by within 20 degrees.

Some embodiments have been described in connection with the accompanying drawings. The figure is drawn in proportion to a certain proportion, but such proportion is not limited. This is because dimensions and ratios other than those shown are also contemplated and within the scope of this disclosure. Distances, angles, etc. are merely examples and may not necessarily be exactly related to the actual dimensions and placement of the illustrated device. Components can be added, removed, and / or reconstructed. Moreover, the disclosure of any particular feature, aspect, method, feature, quality, attribute, element, etc. relating to various embodiments may be used in all other embodiments described herein. Moreover, it will be appreciated that any method described herein can be performed using any device suitable for performing the described steps.

The various features and processes described above may be used independently of each other or in various combinations. All possible combinations and subcombinations are within the scope of this disclosure. In addition, certain methods, events, states, or process blocks may be omitted in some practices. The methods and processes described herein are also not limited to a particular order, and blocks and states relating thereto may be performed in other suitable order. For example, the described work or event may be performed in a different order than the specifically disclosed order. Multiple steps may be combined into a single block or state. The work or event as an example may be performed sequentially, in parallel, or in some other way. The work or event may be added to or removed from the disclosed embodiment as an example. The exemplary system and components described herein may be configured differently than those described. For example, elements may be added, removed, or reconstructed as compared to embodiments as an example of disclosure.

In summary, various embodiments and examples of pressure regulated fluid transfer systems and methods have been disclosed. Although the present disclosure has been described in the context of those embodiments or examples, the present disclosure goes beyond the specifically disclosed embodiments to other alternative embodiments and / or other uses of the embodiments, as well as. Expanded to specific modifications and their equivalents. The present disclosure expressly contemplates that the various features and aspects of the disclosed embodiments may be combined or replaced with each other. Therefore, the scope of this disclosure is not limited by the particular disclosed embodiments described above and should only be determined by reading the following claims correctly.

Claims (18)

A pressure conditioning system configured to transfer a medical liquid from a pressure regulating system into a flexible medical container, said pressure regulating system.
With an adapter assembly, which is configured to connect to a flexible medical container with a variable volume,
A syringe assembly that is detachably connected to the adapter assembly and is configured to reciprocate the medical liquid through the adapter assembly to the flexible medical container.
The syringe assembly
A barrel having a proximal portion, a distal portion, and an inner surface,
Wherein a barrel coaxial, a movable relative to said barrel, a proximal end, a distal end, the at least the distal end is received within the barrel, With the tube
A housing having the barrel and the tube,
A distal seal that connects to the distal end of the tube and slides along the inner surface of the barrel as the tube moves relative to the barrel.
An adjustment reservoir that is partially defined by the rigid side wall of the housing and the distal seal and contains a certain amount of adjustment fluid.
With an access reservoir located within the distal portion of the barrel,
With
The distal seal does not allow fluid to pass through the distal seal between the conditioning reservoir and the access reservoir.
When the fluid is transferred between the syringe assembly and the flexible medical container, the combined volume of the conditioning reservoir and the access reservoir is configured to operate to be adjustable. system. When the adapter assembly and the syringe assembly are connected to the adjusting reservoir and the access reservoir, the adjusting reservoir supplies the adjusting fluid to the flexible medical container, and the access reservoir Configured to receive liquid from said flexible medical container
The pressure adjustment system according to claim 1, wherein when the adapter assembly and the syringe assembly are not connected, the adjustment reservoir and the access reservoir are each substantially isolated from the surrounding environment. The pressure adjustment according to claim 1, wherein when the liquid is transferred from the access reservoir to the flexible medical container, the pressure adjustment is configured to operate so as to reduce the total volume of the adjustment reservoir and the access reservoir. system. The pressure adjustment according to claim 1, wherein when the liquid is transferred from the flexible medical container to the access reservoir, the pressure adjustment is configured to operate so as to increase the total volume of the adjustment reservoir and the access reservoir. system. The pressure according to claim 1, wherein the volume of the adjustment reservoir is configured to operate to be substantially constant when the liquid is transferred between the syringe assembly and the flexible medical container. Adjustment system. A pressure adjusting syringe assembly configured to be connected to a flexible drug container containing a liquid, said pressure adjusting syringe assembly.
An elongated body with a rigid side wall and
A first fluid reservoir arranged in the elongated body, which is configured to accommodate a certain volume of adjusting gas and has a side wall bordering the rigid side wall of the elongated body. 1 fluid reservoir and
A second fluid reservoir located within the elongated body, the second fluid reservoir configured to provide the medical liquid to the flexible drug container .
A distal seal that is slidable along the rigid side wall of the elongated body and does not allow fluid to pass through the distal seal between the first fluid reservoir and the second fluid reservoir. With a seal ,
When the pressure adjusting syringe assembly is connected to the flexible drug container in the opposite position so that the upper surface of the liquid of the flexible drug container is located above the pressure adjusting syringe assembly, the said. It is configured to operate so that the drug liquid is introduced from the second fluid reservoir into the flexible drug container without forming a vacuum in the first fluid reservoir.
Pressure regulating syringe assembly. The pressure-regulating syringe assembly according to claim 6, wherein the flexible drug container has an IV bag. The pressure adjusting syringe assembly according to claim 6, wherein the first fluid reservoir does not have a flexible bag. It ’s a method of transferring liquid,
Connecting the adapter to a variable volume medical container that has a flexible wall and contains diluent,
A syringe comprising a medical liquid reservoir, an adjustment reservoir, a rigid tube having a rigid side wall, and a distal seal that engages with the rigid side wall and seals the medical liquid reservoir from the adjustment reservoir. Connecting the unit to the adapter
Positioning the adapter and the syringe unit below the top surface of the diluent
Pushing down on the plunger of the syringe unit
And extruding the medical fluid from the medical fluid reservoir of the syringe unit,
As at least a portion of the adjustment reservoir of said syringe unit is in contact with the side wall and the boundary of the rigid tube, substantially ambient pressure inside the adjustment reservoir without introducing ambient air into the adjustment reservoir Introducing the medical liquid into the diluent in the variable volume medical container while keeping the pressure at
How to include. To form a mixed solution by mixing the medical liquid and the diluted solution in a medical container having a variable volume.
Retreating the plunger and
Extruding the mixed solution from the variable volume medical container and
Receiving the mixture in the medical liquid reservoir of the syringe unit while keeping the pressure in the conditioning reservoir of the syringe unit substantially ambient.
9. The method of claim 9. 9. The method of claim 9, comprising expanding the variable volume medical container as the medical liquid is introduced into the diluent in the variable volume medical container. The pressure adjustment system according to claim 1, wherein the pressure adjustment system is further configured to operate so that the adjustment fluid does not move from the flexible medical container to the adjustment reservoir. The pressure adjustment system according to claim 1, wherein the adapter assembly does not have an inlet for ambient air. It further comprises a proximal seal, the proximal seal having a first side and a second side, the first side bordering a portion of the first reservoir and said the second. The pressure adjustment system according to claim 1, wherein the side communicates with the surrounding environment. The pressure regulation system according to claim 14, wherein the proximal seal is located radially inside the rigid side wall of the barrel. 14. The pressure regulation system is further configured to act so that the proximal seal moves relative to the housing when the medical liquid is introduced into a variable volume container. Pressure regulation system. The pressure adjustment system according to claim 1, wherein the flexible medical container is an IV bag. A combination of the pressure regulating system according to claim 1 and a flexible medical container.